Suture passer with radiused upper jaw

ABSTRACT

Described herein are suture passers that may be used for repair of the meniscus of the knee. These suture passers typically include an elongate body having a pair of arms. One or more of the arms may be radiused at the distal end region relative to the long axis of the device, to better fit between a target tissue and a body non-target tissue (e.g., the curvature of the femoral condyle). The arms may form a distal-facing opening that is configured to fit the target tissue. One arm may be movable in the axial direction (e.g., the direction of the long axis of the device), while the other arm may be bendable. A tissue penetrator may be housed within one of the arms to extend across the distal opening between the arms. Thus, a suture may be passed from a first side of the tissue to a second side.

CROSS REFERENCE TO RELATED APPLICATIONS

This patent application is a continuation-in-part of U.S. patentapplication Ser. No. 13/873,841, titled “DEVICES, SYSTEMS AND METHODSFOR MENISCUS REPAIR,” filed Apr. 30, 2013, Publication No.US-2013-0238040-A1, which is a continuation of U.S. patent applicationSer. No. 13/462,728, titled “DEVICES, SYSTEMS AND METHODS FOR MENISCUSREPAIR,” filed May 2, 2012, now U.S. Pat. No. 8,449,533, which is acontinuation of U.S. patent application Ser. No. 12/942,803, titled“DEVICES, SYSTEMS AND METHODS FOR MENISCUS REPAIR,” filed Nov. 9, 2010,now U.S. Pat. No. 8,562,631, which claims priority to the following U.S.Provisional Patent Applications: Application No. 61/259,572, titled“DEVICES, SYSTEMS AND METHODS FOR MENISCUS REPAIR,” filed Nov. 9, 2009;Application No. 61/295,354, titled “DEVICES, SYSTEMS AND METHODS FORMENISCUS REPAIR,” filed Jan. 15, 2010; and Application No. 61/318,215titled “CONTINUOUS SUTURE PASSERS HAVING TISSUE PENETRATING SUTURESHUTTLES,” filed Mar. 26, 2010.

This application also claims priority as a continuation-in-part of U.S.patent application Ser. No. 13/893,154, titled “SUTURE PASSER DEVICESAND METHODS,” filed May 13, 2013, Publication No. US-2013-0331865-A1,which is a continuation of U.S. patent application Ser. No. 13/462,773,titled “SUTURE PASSER DEVICES AND METHODS,” filed May 2, 2012, now U.S.Pat. No. 8,465,505, which is a continuation-in-part of U.S. patentapplication Ser. No. 13/323,391, titled “SUTURE PASSER DEVICES ANDMETHODS,” filed Dec. 12, 2011, Publication No. US-2012-0283753-A1, whichclaims priority to U.S. Provisional Patent Applications: Application No.61/483,200, titled “MENISCUS REPAIR,” filed May 6, 2011; and ApplicationNo. 61/511,922, titled “MENISCUS REPAIR,” filed Jul. 26, 2011.

This patent application also claims priority as a continuation-in-partof PCT application no: PCT/US2014/030137, titled “SUTURE PASSER DEVICESAND METHODS,” filed on Mar. 17, 2014.

All of these applications are herein incorporated by reference in theirentirety.

INCORPORATION BY REFERENCE

All publications and patent applications mentioned in this specificationare herein incorporated by reference in their entirety to the sameextent as if each individual publication or patent application wasspecifically and individually indicated to be incorporated by reference.

FIELD

The devices, systems and methods described herein may be useful for thesurgical repair of a torn meniscus. In particular, described herein aresuture passers that are adapted for the effective and reliable passingof a suture to repair a torn meniscus.

BACKGROUND

The meniscus is a C-shaped piece of fibrocartilage which is located atthe peripheral aspect of the joint (e.g., the knee). The central ⅔^(rds)of the meniscus has a limited blood supply while the peripheral ⅓^(rd)typically has an excellent blood supply. Young patients typically teartheir menisci from traumatic events while degenerative tears are commonin older patients as the menisci become increasingly brittle with age.Typically, when the meniscus is damaged, the torn piece begins to movein an abnormal fashion inside the joint, which may lead to pain and lossof function of the joint. Early arthritis can also occur due to thesetears as abnormal mechanical movement of torn meniscal tissue and theloss of the shock absorbing properties of the meniscus commonly lead todestruction of the surrounding articular cartilage. Occasionally, it ispossible to repair a torn meniscus. While this may be donearthroscopically, surgical repair using a suture may be difficultbecause of the difficult-to-reach nature of the procedure and thedifficulty in placing sutures in a way to compresses and secures thetorn surfaces.

Arthroscopy typically involves inserting a fiberoptic telescope that isabout the size of a pencil into the joint through an incision that isapproximately ⅛ inch long. Fluid may then be inserted into the joint todistend the joint and to allow for the visualization of the structureswithin that joint. Then, using miniature instruments which may be assmall as 1/10 of an inch, the structures are examined and the surgery isperformed.

FIGS. 2A-3 illustrate the anatomy of the meniscus in the context of aknee joint. As shown in FIG. 3 the capsule region (the outer edge regionof the meniscus) is vascularized. A typical meniscus has a flattened(“bottom”) and a concave top, and the outer cross-sectional shape issomewhat triangular. The outer edge of the meniscus transitions into thecapsule. FIG. 4 illustrates the various fibers forming a meniscus. Asillustrated in FIG. 4, there are circumferential fibers extending alongthe curved length of the meniscus, as well as radial fibers, and morerandomly distributed mesh network fibers. Because of the relativeorientations and structures of these fibers, and the predominance ofcircumferential fibers, it may be beneficial to repair the meniscus bysuturing radially (vertically) rather than longitudinally(horizontally), depending on the type of repair being performed.

For example, FIGS. 5A-5E illustrate various tear patterns or injuries toa meniscus. Tears may be vertical/longitudinal (FIG. 5A), Oblique (FIG.5B), Degenerative (FIG. 5C), including radially degenerative, Transverseor radial (FIG. 5D) and Horizontal (FIG. 5E). Most prior art devices forsuturing or repairing the meniscus are only capable of reliablyrepairing vertical/longitudinal tears. Such devices are not typicallyrecommended for repair of radial tears, particularly notarthroscopically/minimally invasively. FIGS. 6A-6C illustrate suturesplaced with prior art devices to repair (via suturing) a torn meniscus(showing a longitudinal tear). FIG. 6A illustrates the results of arepair by a Smith&Nephew “Fast-T-Fix” device (comparable to a repair bya Biomet MaxFire device). FIG. 6B illustrates a Cayanne “CrossFix”device, and FIG. 6C illustrates a repair using an Arthrex meniscal“Viper” device.

In FIGS. 6A-6C the devices affecting these repairs require projectionthrough the meniscus and substantially into the capsule region outsideof the meniscus, which could potentially damage the nearby major nervesand large blood vessels. Further, the prior art devices, such as thoseplacing the sutures illustrated in FIG. 6A-6C, typically placehorizontal mattress suture patterns rather than vertical mattress suturepatterns because vertical patterns are considerably more difficult forsurgeons to place when using these devices. Vertical mattress patternswould have improved pull through strength because of the aforementionedpredominance of circumferential collagen fibers found within themeniscus structure. Additionally, the devices forming the suturepatterns illustrated in FIG. 6A-6C are only capable of point fixation;that is they cannot compress the tears uniformly across the tornsurface. Finally, such prior art devices are designed for repairingperipheral vertical meniscus tears (torn from the superior surface tothe inferior surface in line with the C-shape of the meniscus) and areincapable of repairing commonly encountered radial meniscus tears.

Thus, there is a need for methods, devices and systems for repairing atorn meniscus that are compatible with effective suturing. Inparticular, it would be beneficial to provide a device capable ofsuturing both radial and longitudinal tears. The methods, devices andsystems described herein may address this need.

SUMMARY OF THE DISCLOSURE

Described herein are methods, devices and systems for repairing a tornmeniscus. In particular, described herein are methods of repairing ameniscus that has a peripheral vertical meniscal tear or a peripheralradial meniscal tear that are compatible with arthroscopic (minimallyinvasive or semi-minimally invasive) techniques.

In general, the meniscus repair suture passer devices described hereinare configured as suture passers that may pass a suture between two armsor jaw between which the tissue (e.g., meniscus or adjacent tissues) ispositioned. A meniscus repair suture passer may include a first arm(which may also be referred to as a lower arm) that is axially slideablerelative to a second arm (which may also be referred to as an upperarm). The device may also include a tissue penetrator that extendsbetween the arms, preferably in a curved or arcuate path. The tissuepenetrator may secure and release a suture between the first and secondarm.

The “arms” of the suture passer devices described herein may also bereferred to as “jaws” or “members”. Although in some variations the armsare elongate members, they may also be short members; the arms do notneed to (although one or both of them may) extend the length (e.g., thelength of the long axis) of the device. In some variations one or botharms may also be referred to as a shaft. For example, the second arm(“upper arm”) may be referred to as an elongate shaft. In somevariations the upper and lower arms may be included as part of anelongate shaft extending from the proximal to the distal end of thedevice.

The devices described herein may include a plurality of different axes,including a long axis. The long axis may be the longest axis of thedevice, or it may be long axis of the device not including the handleregion, or some other sub-region of the device. For example, the longaxis may define a proximal-to-distal axis of the device. The distal endof the device typically faces away from the handle, towards the patient,while the proximal end of the device typically faces a practitionerholding the device; the proximal end of the device may include a handle,while the distal end of the device engages tissue (e.g., the meniscus).

In general on of the first and second arms may be axially movable (alongthe proximal-distal long axis) relative to each other, and/or relativeto the rest of the device (e.g., a handle, an elongate housing or bodyregion, etc.). In some variations the first arm is extendable ormoveable along the long axis of the device relative to the second arm.The second arm may be fixed relative to the rest of the device, or itmay also be movable relative to the long axis of the rest of the device.Conversely, the second arm may be axially movable or extendable relativeto the first arm, which may be fixed (not movable) relative to the restof the device or also movable. Axial motion may be referred to assliding, pushing, pulling, or the like. This motion is typically in theproximal/distal direction, along the long axis. For reference, themotion of the tissue penetrator as described herein may (in somevariations) be in an axis that is transverse to the long axis of thedevice.

A tissue penetrator is typically an elongate member that passes throughthe tissue and may push and/or pull a suture shuttle with it. Althoughin some variations the tissue penetrator may directly connect to asuture, in the principle embodiments described herein the tissuepenetrator is configured for indirect coupling with a suture. This isdescribed in greater detail below. A tissue penetrator may be solid orhollow, and may be curved, straight or bendable/curveable. In somevariations the tissue penetrator has a sharp and/or pointed distal end.In some variations the tissue penetrator has one or more regions forengaging a suture or suture shuttle. For example, the tissue penetratormay include a clamping or anchoring region for releasably securing asuture.

In general, the first and second arms of the meniscus repair suturedevices described herein may be positioned to form an opening(preferably an actute angled opening such as a v-shaped opening) whenthe first arm is extended relative to the second arm. This opening maybe configured to correspond (or be slightly wider than) the angle of thesuperior surface and inferior (undersurface) of a meniscus. Asmentioned, the meniscus are typically C-shaped fibrocartilaginousstructures attached to the condylar surface of the tibia. The limbs ofthe C face centrally. The superior meniscal surface is generally concave(e.g., radiused), which enhances contact with the curvilinear-shapedfemoral condyle. Conversely, the undersurface of the meniscus isgenerally flat, which enhances contact with the flattened tibialplateau. The periphery (outer portion) of the meniscus is thicker thanthe pointed central portion. The thick periphery allows for a firmattachment to the joint capsule. Thus, in general, the first and secondarms of the devices described herein may be configured to fit thisgeneric anatomy (and may be sized to fit specific anatomies or ranges ofanatomies). For example, the first arm may be straight and configured tofit beneath the flat undersurface of the meniscus, while the second armforms a bend with the first arm approximating the angle between thesuperior surface and undersurface of the meniscus (e.g., the maximumangle, or an average of the angle of this somewhat convex surface).

For example, the distal opening of the devices formed between the firstand second arms may be an acute-angled distal facing opening configuredto fit the meniscus therein. The distal opening may be a v-shaped distalopening between the second and first arms when the first arm is extendeddistally relative to the second arm, configured to receive a meniscus.

In general, when the first arm, which may be “straight” or extending inthe same direction as the long axis of the device, is retractedproximally, this lower “arm” of the distal opening is missing, so thedevice has just a narrow, bent, distal end formed by the distal endregion of the second arm. This distal end region may be used to positionthe device within the knee near the meniscus. The small size anddimensions of the distal end when the first arm is retracted proximally(completely) may allow the device to navigate the tissue of the kneewithout undue damage to other tissues. Extending the first (lower) armdistally may form the “v-shape” mentioned above. In general, the tips ofthe distal ends of the second and first arms may be rounded andatraumatic. In particular, the tips may be blunt to prevent damage totissue as the device is positioned.

In some variations, the tissue penetrator is configured to be housedwithin the distal end of the first arm. The tissue penetrator may becompletely retracted into the first arm, which may prevent damage totissue as the device is maneuvered into position around the meniscus. Insome variations, the tissue penetrator is configured to extend from thesecond, rather than the first arm, in which case the configuration ofthe tissue penetrator and dock (e.g., shuttle dock) may be reversed.

The meniscus repair suture devices described herein may also include aproximal handle having a first control for axially moving at least thedistal end region of the first arm relative to the second arm. Aproximal handle may be configured for gripping (in a single hand orusing both hands), and may have a tissue penetrator control forcontrolling the extension and retraction of the tissue penetrator acrossthe distal opening formed by the second arm and the extended first arm.

The tissue penetrator may be configured to extend across the distalopening in a curved path. For example, the tissue penetrator may becurved or curveable (e.g., via a hinged region, shape-memory material,etc.). In general, the tissue penetrator may include a clip region towhich a suture shuttle may releasably secure.

Any of the devices described herein may be configured for re-use. Forexample, in some variations a portion of the device is “durable”(re-usable) and a portion of the device is disposable. For example, insome variations the second arm is configured to be detachable from thedevice, and disposed of. In some variations the second arm includes asuture shuttle and/or an attached suture that is pre-loaded into thesecond arm (or shaft). Thus, in some variations, the second arm isconfigured to be disposable and to detachably connect to a reusablefirst arm.

The first arm may be extended or retracted axially as mentioned above.In general, the first arm may include a final stop that limits orprevents the movement of the first arm distally along the long axis ofthe device by preventing the first arm from extending beyond this stop.For example, the final stop may prevent the distal tip of the first armfrom extending beyond a position on the device in which the tip of thefirst arm and the tip of the second arm form a right angle relative tothe long axis of the device, which may be the same as the long axis ofthe first arm.

In some variations, the devices described herein include a plurality of“stops” that indicate to a user the axial position of the first armalong the distal to proximal long axis of the device. These stops,unlike the final stop, may not prevent axial movement of the first armrelative to the device, but they may indicate positions in which thefirst arm of the device may be held static by some manner, or where aslight increase in resistance to axial motion may be felt. Thesepositions may correspond to known positions of the first arm relative tothe upper arm (e.g., fully withdrawn, extended halfway across thedevice, fully extended, or intermediate positions between these). Insome variations these stop positions may correspond to positions inwhich the tissue penetrator, if extended while the first arm is at thisstop position, will engage a shuttle dock.

Any of the devices and components described herein may be included aspart of a kit. For example, described herein are kits comprising ameniscus repair suture passer and a suture shuttle. In some variationsthe kit includes a suture. In some variations the kit may include aremovable (or multiple removable) second arm or shaft region. Thissecond arm may include one or more suture passers pre-loaded with asuture.

For example, described herein are suture passer devices for passing asuture through a tissue (such as a meniscus in a knee), and particularlydevices for minimally invasive procedures, such as arthroscopicprocedures. Any of these devices may include: an elongate body having alength and extending distally and proximally along a long axis; a firstarm extending from the distal end of the elongate body, a second armextending distally from the elongate body, wherein an upper surface ofthe second arm is radiused and curves away from the long axis; furtherwherein the first arm and the second arm form a distal-facing openingbetween the second arm and the first arm; and a tissue penetratorconfigured to extend across the distal-facing opening between the firstand second arms to pass a suture there between, wherein the tissuepenetrator is housed within either the first arm or the second arm.

In general, any of the suture passer devices described herein may have ajaw (or “arm”) member that is radiused on at least an outer surface(e.g., the surface facing away from the distal-facing jaw formed with asecond jaw/arm member). A radiused jaw member typically includes a jawmember having a surface that is curved with a radius of curvature thatis configured to conform to the curvature of a body region, such as thecurvature of the femoral condyle. This may allow better access of thedevice (e.g., the radiused jaw member) into the posterior or peripheralregion of the knee. For example, the radius of curvature may be betweenabout 0.5 cm and about 20 cm (e.g., between about 0.5 cm and about 10cm, between about 1 cm and about 10 cm, between about 1 cm and about 5cm, between about 0.5 cm and about 5 cm, between about 2 cm and about 5cm, about 2 cm, about 3 cm, about 3.5 cm, about 4 cm, about 5 cm, etc.).

In any of the variations described herein, the first arm may beconnected to the elongate body and may be axially movable distally andproximally relative to the elongate body along the long axis. The tissuepenetrator may be housed within the first arm, including entirely housedwithin the first arm (e.g., with the distal tip within the first arm) sothat the distal tip of the tissue penetrator (which may also be referredto herein as a needle) may be extended and retracted into the first arm.When extending and retracting the tissue penetrator from the arm inwhich it is housed (e.g., either the first or second arm), the distalend (tip) of the tissue penetrator may be extended from the arm in whichit is housed, deflected from the housing and extended across thedistal-facing opening to reach the opposite arm/jaw member (e.g., thesecond arm), where it may be deflected a second time before extendingeither distally or proximally along the opposite arm. During extensionand/or retraction of the tissue penetrator from the arm housing it, theproximal end of the tissue penetrator typically remains in the armhousing it. The tissue penetrator may be preloaded with a suture andboth the tissue penetrator and suture may be housed within an arm (e.g.,the first arm) until it is extended between the distal-facing jaw formedby the two jaws (upper and lower). The tissue penetrator may be formedof any appropriate material, including a shape memory alloy.

The first arm may be configured to move axially in the long axis, asdescribed herein. The second arm may be pivotably attached to the distalend region of the elongate body. The tissue penetrator may be configuredto releasably couple to the suture to carry the suture through a tissue.

The distal-facing opening may generally be an acute-angled distal-facingopening configured to fit a meniscus therein.

For example, a suture passer device for passing a suture through ameniscus may include: an elongate body extending distally and proximallyalong a long axis; a first arm that extends from the elongate body andis axially movable distally and proximally relative to the elongate bodyalong the long axis; a second arm extending distally from the elongatebody, wherein an upper surface of the second arm is radiused with aradius of curvature of between about 0.5 cm and about 20 cm and curvesaway from the long axis; further wherein the first arm and the secondarm form a distal-facing opening between the second arm and the firstarm; and a tissue penetrator configured to extend across the distalopening between the first and second arms to pass the suture therebetween.

A suture passer device for passing a suture through the meniscus mayinclude: an elongate body having a length and extending distally andproximally along a long axis; a first arm that is axially movabledistally and proximally relative to the elongate body along the longaxis, a second arm extending distally from the elongate body, wherein anupper surface of the second arm is radiused with a radius of curvatureof between about one-tenth the length of the elongate body and about thelength of the elongate body and curves away from the long axis; furtherwherein the second arm is pivotably attached to a distal end region ofthe elongate body and the first arm and second arm form a distal-facingopening between the distal region of the second arm and the distalregion of the removable first arm when the removable first arm isextended distally; and a tissue penetrator housed within the first armthat is configured to extend across the distal-facing opening to pass asuture there between.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a schematic of a portion of a torn meniscus between afemur and tibia and a suture passer to the right.

FIGS. 1B-1D illustrate insertion of a suture passer surgical device intothe joint and around the torn meniscus. The upper surface (surfacefacing the femoral condyle) of the upper jaw in this example is radiusedand curves away from the long axis.

FIGS. 1E-1H illustrate passing the suture through the meniscus multipletimes using the suture passer as described herein.

FIGS. 1I-1M illustrate removal of the suture passer, retaining thesuture in position.

FIGS. 2A and 2B illustrate the anatomy of the meniscus.

FIG. 3 illustrates the anatomy of the meniscus, including the capsuleand associated vascular tissue.

FIG. 4 illustrates the structure of a meniscus.

FIGS. 5A-5E illustrate various tear patterns of a meniscus that may berepaired using the invention described herein.

FIGS. 6A-6C illustrate meniscus repair using prior art devices.

FIG. 6D illustrates meniscus repair using a device as described herein.

FIG. 7A shows one variation of a meniscus repair suture passer asdescribed herein. The upper surface (surface facing the femoral condyle)of the upper jaw in this example is radiused and curves away from thelong axis.

FIGS. 7B-7D illustrate various preset (e.g., ‘lock’) positions for themeniscus repair suture passer shown in FIG. 7A.

FIG. 8 shows another variation of a meniscus repair suture passer asdescribed herein.

FIG. 9A shows one variation of a meniscus repair suture passer. Theupper surface (surface facing the femoral condyle) of the upper jaw inthis example is radiused and curves away from the long axis

FIGS. 9B and 9C show another variation of a meniscus repair suturepasser.

FIGS. 10A and 10B illustrate one variation of a meniscus repair suturepasser, also having an upper surface (surface facing the femoralcondyle) of the upper jaw in this example is radiused and curves awayfrom the long axis

FIGS. 10C and 10D show a meniscus repair suture passer from twodifferent side perspective views in which the upper (bent) arm extendedand the lower (straight) arm retracted.

FIGS. 10E and 10F show the meniscus repair suture passer of FIGS. 10Cand 10D after the lower (straight) arm has been extended.

FIGS. 10G and 10H show the meniscus repair suture passer of FIGS. 10Cand 10D after the lower (straight) arm has been extended and the curvedtissue penetrator has been extended.

FIG. 11A-11 i illustrate use of a meniscus repair suture passerrepairing a radial tear in a meniscus.

FIGS. 12A and 12B illustrate exemplary dimensions and interaction offirst and second (lower and upper) arms and a tissue penetrator when thefirst arm is fully (FIG. 12A) and partially (FIG. 12B) extended in oneexample of a device and method of operating a device. The dimensionsillustrated are exemplary only, and any of the variations of the deviceshown herein may be formed having other dimensions, including dimensionsthat are collectively or individually scaled to be between approximately+/−25% and 200% of the values shown.

FIGS. 13A and 13B show one variation of a curved tissue penetrator in arelaxed and curved (FIG. 13A) and a straightened (FIG. 13B)configuration.

FIGS. 14A and 14B illustrate the curved tissue penetrator of FIGS. 13Aand 13B retracted into the lower arm/jaw (FIG. 14A) and extending fromthe lower arm/jaw (FIG. 14B) to pass a suture shuttle from the lower tothe upper arm/jaw.

FIG. 14C illustrates another variation of a curved or curvable tissuepenetrator.

FIGS. 15A and 15B illustrate one embodiment of a suture shuttle.

FIGS. 16A and 16B illustrate another embodiment of the suture shuttle.

FIG. 17 illustrates yet another embodiment of the suture shuttle.

FIG. 18 illustrates one embodiment of a tissue penetrator.

FIGS. 19A-19D illustrate one embodiment of the interaction between thesuture shuttle and the tissue penetrator.

FIG. 20 illustrates a first embodiment of a suture clip.

FIG. 21A shows one variation of a tissue-penetrating suture shuttle(with a connected suture) connected/coupled to a tissue penetratingelement.

FIG. 21B shows the tissue penetrating suture shuttle of FIG. 21Aseparated from the tissue penetrating element.

FIG. 21C shows an enlarged view of the distal tip region of the tissuepenetrating element shown in FIG. 21A.

FIGS. 22A-22B show another variation of a tissue penetrating sutureshuttle and tissue penetrator, in side perspective views. FIG. 22B showsthe distal tissue penetrating suture shuttle separated from the tissuepenetrating element of the device.

FIG. 23 illustrates a section though a knee indicating one method ofapproach for repairing a meniscus as described herein.

FIGS. 24A to 24C illustrate one method of positioning a meniscus repairsuture passer around the meniscus.

FIGS. 25A and 25B show a generic form of a dual deployment suturepasser.

FIGS. 26A-26C illustrate a generic variation of a suture passerincluding a tissue penetrator traveling in a sigmoidal path in which thedistal end of the tissue penetrator extends distally from the upper jaw.

FIG. 27A is another variation of a suture passer having a tissuepenetrator that extends distally from the upper jaw; FIG. 27Billustrates the motion of the upper and lower jaw of the suture passerof FIG. 27A.

FIG. 27C is another variation of a suture passer having a tissuepenetrator that extends distally from the upper jaw; FIG. 27Dillustrates the motion of the upper jaw of the suture passer of FIG.27C.

FIG. 27E is another variation of a suture passer having a tissuepenetrator that extends distally from the upper jaw; FIG. 27Fillustrates the motion of the lower jaw of the suture passer of FIG.27A.

FIG. 28A illustrates different paths for a tissue penetrator in a suturepasser having an upper jaw member that pivots.

FIGS. 28B-28E illustrate sigmoidal paths that may be taken by a tissuepenetrator as described herein.

FIGS. 29A and 29B show top and side views, respectively of one variationof a tissue penetrator.

FIGS. 30A-30E illustrate operation of one variation of a suture passerhaving a tissue penetrator that extends distally from the upper jaw andtravels in a sigmoidal path.

FIGS. 31A-31B show side perspective views of one variation of an upperjaw member for a suture passer such as the suture passer shown in FIG.30A.

FIGS. 32A-32B show side perspective views of another variation of anupper jaw member for a suture passer including a suture stripper.

FIGS. 33A, 33B and 33C show another variation of a suture passer.

FIGS. 34A, 34B, and 34D show top and two side perspective views,respectively of the distal end of the suture passer shown in FIG. 33A.

FIG. 34C illustrates the arrangement of the tissue penetrator and suturestripper in the distal end region of the suture passer of FIG. 33A.

FIGS. 35A-35C show a suture stripper including a stripper plate (FIG.35B) and base (FIG. 35C).

FIGS. 36A and 36B show side perspective views of the distal end regionof a jaw member including a suture stripper.

FIGS. 37A-37C illustrate variations of a first jaw (e.g., upper jaw) ofa suture passer device having different thicknesses.

FIG. 38A shows an upper jaw having a radiused (curved) outer surfacenear the proximal region and a uniform thickness along much of thelength. FIG. 38B shows an upper jaw having a straight (un-curved)proximal region and a uniform thickness along much of the length.

FIG. 38C shows an overlaid view of the upper jaws of FIGS. 38A and 38B,showing the differences in curvature near the proximal end regions.

FIG. 38D shows a hybrid upper jaw having a curved (radiused) uppersurface and a straight lower, tissue-contacting, surface. The hybridupper jaw is thinner in width proximally than distally.

FIGS. 39A, 39B and 39C show side, bottom perspective and side sectionalviews, respectively, of another variation of an upper jaw having aradiused (curved) outer surface near the proximal region and arelatively flat inner/lower surface opposite the outer surface, as wellas a suture capture region at the distal end.

DETAILED DESCRIPTION

Described herein are suture passers for meniscus repair. In general,these devices may be referred to herein as meniscus repair suturepassers, meniscus repair devices, or simply suture passers. The devicesdescribed herein may be configured to repair a meniscus (knee jointmeniscus), and may have two arms which extend longitudinally and can beexpanded around a meniscus from a lateral (central) approach. Differentvariations of the devices described herein may also be referred to assnake-tongue, sigmoidal, dual deployment suture passers, and/orclamping/sliding suture passers.

Typically, the distal end region (e.g., the distal-most 3 or less cm) ofone of the arms may be bent or bendable at an angle away from the longaxis of the device, and the other arm may be axially movable distallyand proximally (in the direction of the long axis of the device).Extending the distally and proximally movable arm distally will form anacute angled opening at the distal end that can be positioned around themeniscus, and a suture can be passed from one arm to the other throughthe meniscus or adjacent tissues to repair meniscal tears. The suturemay be passed through the tissue multiple times by using a tissuepenetrator that can extend and retract from just one of the arms to movesuture between the two arms.

In any of the devices described herein, the upper jaw/arm member may beradiused and curves away from the long axis of the device (e.g., of theelongate member connecting the proximal handle region to the distaljaw/arm members). As illustrated and described in greater detail below,the radius of curvature may be between about 0.5 cm and about 20 cm(e.g., between about 0.5 cm and about 10 cm, between about 1 cm andabout 10 cm, between about 1 cm and about 5 cm, between about 0.5 cm andabout 5 cm, between about 2 cm and about 5 cm, about 2 cm, about 3 cm,about 3.5 cm, about 4 cm, about 5 cm, etc.).

Thus, the meniscus repair suture passer devices described herein maypass a suture once, twice, or more than two times through the meniscusso that the suture passes over the top and bottom of the meniscus. Theangle and/or position of the device may be adjusted as necessary beforeand during the procedure, including between passing the suture throughvarious portions of the meniscus. Thus, the meniscus repair suturepassers describe herein are adapted for percutaneous use.

In some of the exemplary devices described herein, a suture “shuttle” isused to connect a suture to the suture passer (e.g., the tissuepenetrator or needle). As discussed herein and illustrated in thefigures, this suture shuttle is optional; any of the features of thedevices described herein may be included in apparatus that do notinclude a shuttle. Thus, the tissue penetrator may be adapted todirectly hold and release a suture or loop of suture.

For example, a system including a suture passer as described herein mayinclude a first arm, a second arm, a suture-passing tissue penetratingelement (e.g., needle), a shuttle for passing a suture, and one or moreshuttle seats for releaseably retaining and releasing the sutureshuttle. In some variations the tissue penetrating element is a curvedneedle element that is configured to extend from the first or second arm(from which it may be extended and retracted), through tissue (or air),and approach the second or first arm, where it may engage or disengage(alternately or cyclically) a suture shuttle held in a shuttle seat. Insome variations, the first arm of the suture passer may be configuredfor axial movement (e.g., forward and backwards along the long axis ofthe device). The suture passer may be configured so that the first armincludes two or more stops. For example, the first arm may include afirst stop in which the first arm is fully retracted axially, so thatthe first arm is retraced proximally while the second arm extendsdistally, and a second stop (extended stop) when the first arm is fullyextended distally so that the tissue penetrating element (e.g., needle)may be extended from the first arm to engage a shuttle seat on thesecond arm. In some variations the suture passer includes a third ormore (e.g., intermediate) stop(s) in which the first arm is partiallyextended distally at a position where the tissue penetrating element maybe extended from the first arm to engage a second shuttle seat on thesecond arm. This is illustrated in FIGS. 7B-7D, described below.

One or more arms of the suture passer may be bent or curved. Forexample, the second arm of the device may be bent, curved, or angled(e.g., “upwards” away from the first arm, or from the long axis of thedevice, including the first arm) so that the ends region of the secondarm (the upper arm) relative to the long axis is bent at approximatelythe angle of the meniscus (e.g., the superior face of the meniscus). Theangle may be fixed (e.g., at an acute angle of approximately 10°, 15°,20°, 25°, 25°, 30°, 35°, 40°, 45°, 60°, etc. including any angle between1° and 90°). For example, the angle may be between 20 degrees and 50degrees. In some variations, the angle between the first and second armsis variable (e.g., either or both arms may be bent or adjusted to adjustthe angle therebetween). The angle of the bend in the upper (second) armmay be approximately the average angle between the superior and inferiorfaces of the meniscus; for example, the angle may be approximately 35degrees +/−2 degrees, 5 degrees, 7 degrees, 10 degrees, 15 degrees, etc.In general the bend forms an acute angle with the lower (second) armwhen the second arm is extended distally. In some variations, asmentioned, the distal end region of the second arm may be bendable froma straight or pre-bent configuration into the final bend configuration.

Alternatively and/or additionally, an arm of the suture passer(including the same arm that is bent or bendable) may be radiused, sothat at least an upper surface of the arm (e.g., the upper surface maycorrespond to the surface facing away from the opposite arm) is curvedaway from the long axis of the device.

As mentioned, the second arm may include one or more shuttle seats. Ingeneral, the shuttle seats may be configured to releasably engage asuture shuttle to which the suture can be connected. The suture shuttleis thereby passed between the shuttle seat on the second arm and thetissue penetrating element that may extend and retract into the firstarm. The suture shuttle and tissue penetrating element may be configuredas described in the descriptions previously incorporated by reference(as well as U.S. 2010/0331863 and U.S. 2013/0253647, herein incorporatedby reference in their entirety). For example, the shuttle may be a clip(e.g., a triangular-shaped clip) to which a suture is secured; the clipmay be configured to snap on an off of the tissue penetrating element(e.g., a curved needle having a triangular cross-section). In somevariations, the suture shuttle with a suture attached is pre-loaded intothe distal-most shuttle seat on the first arm of the device. FIGS.15A-22B, described in more detail below, illustrate some variations ofsuture shuttles and attachment regions to various tissue penetrators.

A tissue penetrating element may be a curved member that retracts orextends from one of the arms. In particular, a tissue penetrating membermay be a curved or curveable (e.g., bendable) element that retractscompletely into a housing in the distal end region of the first arm, andextends outwards in a curved pathway. In some variations, the tissuepenetrator may be configured to extend from the distal end region of thesecond arm, and to retract fully into the body of the second arm; insome variations a portion of the tissue penetrating member may extendfrom the first arm even when fully retracted into the first arm. Thesecond arm or other portions of the suture passer may be configured toinclude a track or pathway for the tissue penetrating member so that thetissue penetrating member does not prevent the first arm from extendingor retracting axially relative to the body of the device.

FIGS. 1A-1M show one variation of a suture passer used to repair a tornmeniscus. These figures illustrate the operation of the device to repaira peripheral vertical tear in a meniscus.

For example, FIG. 1A shows a sagittal cross-section through a patient'sknee. A portion of the meniscus is shown. The vertical tear 101 (shownas a line) in the peripheral region of the meniscus 100 is illustrated.The femur is shown above the tibia, with the torn edge of the meniscusbetween the two. One variation of a continuous suture passer 103 isshown to the right of the cross-section through the knee. The suturepasser may be inserted into the joint via an arthroscopic or an open (orsemi-open) surgical procedure. For example, in some variations the tornmeniscus may be accessed and visualized arthroscopically; the suturepasser may be inserted through a separate incision or through the sameincision.

In this example, the suture passer is inserted in a collapsed orretracted configuration, in which the first arm 105 is retractedproximally (e.g., towards a handle or control at the proximal end). Thesecond arm 102 extends from the distal end (and may be fixed in thisextended position, or it may be adjustable or extendable). The secondarm 102 shown in this configuration is curved (‘upwards’) so that it canbe inserted around the torn meniscus, as shown in FIGS. 1B-1C. Thus, asshown, the second arm 102 is radiused and curves relative to the longaxis of the device 103 (the region proximal to the second arm 102) witha radius of curvature that is approximately the same as femoral condyleregion in FIG. 1A; as is known to those of skill in the art, the radiusof curvature of the femoral condyle may be between about 0.5 cm (inpediatric patients) and about 4.5 cm, e.g., between about 3 cm and about4.5 cm in adults.

The entire suture passer is sized for use in this space. For example,the suture passer may have a diameter in the un-extended/deliveryconfiguration that is less than a typical (or size-appropriate) spacebetween the femur and tibia, i.e., less than about 10 mm, less thanabout 9 mm, less than about 8 mm, less than about 7 mm, less than about6 mm, etc. This diameter may include the diameter of the first arm,which may have an individual diameter of less than about 5 mm, less thanabout 4 mm, less than about 3 mm, less than about 2 mm, etc.

The distal end of the suture passer, formed by the distal end region ofthe second arm, may thus be extended into the tissue and above the tornmeniscus, as illustrated in FIGS. 1A-1C. Once the second (upper) arm ispositioned, the first (lower) arm 105 may be extended from the device,as illustrated in FIG. 1D. In this example, the first arm is extendedfrom the proximal region of the device, so that it may extend under themeniscus, opposite from the second arm. The first arm may be straight(as shown in FIGS. 1A-1K), or it may be curved or bendable.

In the illustrated method of FIGS. 1A-1K, the first, lower, arm isextendable axially from the body of the device. The lower arm extendsforward by sliding underneath the inferior surface of the meniscus andtowards the capsule of the underside of the meniscus. The lower arm maybe extended to the most distal “stop.” The distal stop may be indicatedby a resistance (e.g. a physical stop), and may be locking. For example,the second arm may click into position when held in a stop on the suturepasser. A handle or control on the device may be used to disengage andwithdraw the device.

Once the first arm is in the desired axial position (e.g., fullyextended or otherwise) relative to the first arm, the suture may bepassed. For example, FIG. 1E illustrates the initial step of extendingthe tissue penetrating element (needle) 111 from within the first armand across the space separating the first and second arms. In thisvariation, the tissue penetrating element is a curved needle that ispushed from the distal end region of the device as illustrated to passthrough the meniscus as shown. Initially, the tissue penetrating memberjust forms a pathway through the tissue; the shuttle and suture are heldwithin the second arm. In this example, the needle penetrates throughthe peripheral menisocapsular tissue and mates with a complementaryregion of the second arm, the first distal shuttle seat. The shuttle andan attached suture are initially pre-loaded into the distal shuttleseat. Contacting the shuttle seat with the tissue penetrating memberwhen the shuttle is already held in the shuttle seat may cause theshuttle to snap onto tissue penetrating member, and release the shuttlefrom the seat, as illustrated in FIG. 1E. Thereafter, the shuttle andany attached suture 113 may be withdrawn back through the meniscus onthe tissue penetrating member as it is retracted into the second arm, asillustrated in FIG. 1F. The suture is thereby drawn across and throughthe meniscus.

In some variations the device is configured so that the tissuepenetrating element (e.g., needle, etc.) may be extended only when thelower arm is extended to a position from which the tissue penetratingelement may mate with the receiving site (e.g., shuttle seat) on theopposite arm.

In FIG. 1G, the first (lower) arm 105 can then be retracted slightly. Inany of these variations, the arms may be referred to as forming a “jaw”and thus the second arm may be referred to as the upper or second jawand the first arm may be referred to as the first or lower jaw. In thisexample, the first arm is retracted into a stop position that is locatedproximal to the distal end. This second stop may be referred to as theintermediate or second stop position (the distal end position is thefirst or distal stop, and the fully retracted position may be referredto as the proximal stop position). The device may hold or releasably“lock” the first arm in this position so that the tissue penetratingmember (to which the shuttle is now attached) may be extended backthrough the meniscus, in a region located more peripheral to the tear,as illustrated in FIGS. 1G and 1H. Meanwhile, the upper (second) arm isleft securely in place. In some variation (e.g., anatomy permitting),the second arm may also be slightly withdrawn proximally, or the entiredevice may be moved laterally or proximally to position an additionalstitch at a different position.

In some of the variations described herein, the lower arm (e.g., the armincluding the tissue penetrating element) may be longitudinallyextended/retracted relative to the rest of the device. In somevariations the upper arm may be extended/retracted relative to the restof the device. This is illustrated below in the variations shown inFIGS. 9-10B.

Returning now to FIG. 1H, the tissue penetrating member with attachedshuttle and suture is again extended, this time penetrating on theopposite side of the tear from the previous stitch, so that the tear maybe stitched closed. The needle is passed until it engages (distally)with a second shuttle seat region of the second arm; when this occursthe shuttle is held securing in the shuttle seat and is uncoupled (e.g.,unclipped, or removed) from the tissue penetrating element, so that thetissue penetrating element can be withdrawn to leave the shuttle behindin the shuttle seat on the second arm, as illustrated in FIG. 1I. Insome variations the suture passer may be moved slightly (e.g., laterallyout of the plane of the cross-section shown) to again pass the suture byrepeating some of the steps above, e.g., from FIGS. 1E forwards, or itmay be removed.

In FIG. 1J, the first arm (and thus the device) is withdrawn axially(proximally), so that the device may be removed, as shown in FIG. 1K.Removing the device leaves the suture passed through the meniscus, asillustrated in FIG. 1L. The suture maybe drawn through the tissue,leaving the loop through the tissue behind. A knot may then be tied orthe suture may otherwise be secured, as illustrated in FIG. 1M. Apre-tied knot may be pre-packaged to slide into place as the device iswithdrawn.

FIG. 6D illustrates one variation of a suture made through a region ofthe meniscus having a longitudinal tear. The resulting suture may becompared with other types of suture fixations (“stitches”) made by otherdevices, as discussed in the background section above, relative to FIGS.6A-6C. In comparison, the meniscus suture devices described herein maypass a suture through the meniscus near the boundary (or just past theboundary) of the capsule region (to the right of the figure in FIG. 6D).Because the device may pass the suture vertically through the meniscus(as illustrated in FIGS. 1A-1M), and because of the orientation andconfiguration of the tissue penetrating element, the suture may bepassed without risk of plunging deep into and beyond the capsule regionof the knee. This design may prevent injury to nearby nerves andvascular tissues (e.g., blood vessels). In addition, the suture maybepassed over and around the outside regions of the capsule, asillustrated.

FIG. 7A illustrates one variation of a meniscus repair suture passer. Inthis example, the suture passer includes an upper (“second”) jaw or armthat extends longitudinally from the elongate body and curves up (out ofthe longitudinal axis) as illustrated. This second jaw member has aradiused outer surface, as mentioned above. The lower “jaw” or arm(first arm) member is slideable relative to the upper arm, and can beextended in the longitudinal axis of the device and held in any of threepositions, as illustrated in FIGS. 7B-7D. These positions are labeled“1^(st) position,” in which the lower arm is fully retracted, as shownin FIG. 7B. A control, slider member (shown as a finger or thumb sliderin FIG. 7A), may be used to axially move (e.g., slide) the lower armforward or back (or to hold the lower arm stable while moving the restof the device forward/back relative to the lower arm). The secondposition, shown in FIG. 7C is fully extended. As mentioned, the devicemay include a lock or bias to hold the arms in this position once slidor otherwise moved here. For example, the device may include aspring-lock that can be engaged (releasably) to hold it in position,allowing the tissue penetrator to be extended or retracted as describedabove. Finally, FIG. 7D illustrates a third, intermediate, position ofthe first arm, which may also be locked, and for which a correspondingmating site (e.g., docking site) for the tissue penetrating element mayalso be present. The intermediate position (3^(rd) position) may beoptional. In some variations additional intermediate positions may alsobe included.

A separate mechanism may be used to extend/retract the tissuepenetrating element from the lower arm to engage the upper arm. Forexample, a trigger may be included. In FIG. 7A and FIG. 8, the deviceincludes a push element 701 within the cannula of the elongate body thatallows the tissue penetrating element to be extended/retracted. Asmentioned the device may be configured to prevent the tissue penetratingelement from extending (or retracting) when the arms forming the openingare not aligned so that tissue penetrating element will not extendunless it can engage a shuttle dock region (and couple with/release thesuture shuttle and/or suture). For example, the tissue penetrator may beallowed to extend from the device only when the lower arm is in thesecond or third positions.

The shuttle dock region may be configured to alternatively lock (hold)and release the suture shuttle, depending on whether the suture shuttleis already present within the dock. This may allow the suture (andshuttle) to be released or retained by dock/tissue penetrator and pulledthrough the tissue alternatively, allowing continuous suturing.

In some variations, the upper or lower arm is removable or replaceable.For example, the device may be modular. FIGS. 9A and 9B illustratesvariations of meniscus suture passer devices having a modular designallowing various upper arms to be connected to the rest of the device,as shown in FIG. 9C. In this example, the principles of which may begeneralized to other variations (e.g., in which the lower arm isreplaceable), the upper arm may be pre-loaded with a suture (which maybe coupled to a shuttle). Different, interchangeable, upper arms may beused that include different structures. For example, different upperarms may have different bend angles of the arm relative to the long axisof the device (e.g., between 10 and 60 degrees, as indicated above). Insome variations the device may have different lengths, widths, and/orthicknesses. In some variations different upper arms may be selectedbased on the number and/or locations of the shuttle docks on the arm.Although this section refers to the jaw or arms as the modular orinterchangeable feature of the device, the actual interchangeable regionmay include the bent distal end region of the upper arm and the un-bentelongate portion, as seen in FIG. 9A and 9B. In this example, theinterchangeable region 902 also includes a grip region 905 that may beused to couple the second arm to the rest of the device, and may beuseful in variations in which the upper arm (second arm) is axiallymovable relative to the handle. FIGS. 9B and 9C illustrate thisvariation in slightly more detail, showing the disposable and preloadedupper arm 902 and a potentially re-usable or durable lower arm that maybe combined to form the meniscus suture passer device 900 shown in FIG.9C. The durable portion may be sterilizable so that it can be re-usedwith multiple patients, or it may be merely used to pass multiplesutures for a single patient.

In operation, a user may measure or probe the meniscus region (includingnon-invasive imaging) to determine which upper arm to select. The upperarm may then be coupled with the rest of the device, including the lowerarm and handle. The upper arm may be coupled to the rest of the deviceby a snap-fit, a lock, and/or any other mechanical, magnetic, etc.connection means that may be used to link the upper arm with the rest ofthe device.

As mentioned above, in some variations the upper arm is held relativelystationary relative to the rest of the device (e.g., the handle,elongate body, etc.) and the lower arm is axially extended/retracted. Insome variations, including the variation shown in FIGS. 9A-9C, the upperarm is axially extendable/retractable. For example, the upper arm may beattached to the meniscus repair device and allowed to slide forward orretracted. The lower arm may also be configured to slide axially, or itmay be held fixed relative to the rest of the device (e.g., the handleregion).

FIGS. 10A and 10B illustrate another variation of a meniscus suturepasser device in which the upper and lower arms may be moved axially andindividually locked into position.

The various configuration of the upper and lower arm relative to eachother in one variation of a meniscus repair suture passer device areillustrated in FIGS. 10C to 10H. For example, FIGS. 10C and 10Dillustrate two perspective views of one variation of a meniscus repairsuture passer device 1001 having an elongate first arm 1003 that isaxially movable (in the dorsal/proximal long axis of the device 1005)relative to the rest of the device, including a second arm 1007. Theelongate second arm 1007 extends adjacent to the first arm along thelong axis 1005 of the device. The elongate second arm also includes abent distal end region 1009 that may be bent relative at an anglerelative to the long axis of the device, as shown. The distal tip ofthis distal end region is atraumatic, and is shown as substantiallyblunt. In FIGS. 10C and 10D, the first arm is retracted proximally sothat it does not form a distal opening in this position.

FIGS. 10E and 10F illustrate an extended position in which the distalend region of the first arm 1011 has been extended distally towards thedistal end region 1009 of the upper arm (second arm 1007). The distalend regions of the first and second arms 1009, 1011 have formed a distalopening between the first and second arms 1014. The exit for the tissuepenetrator is visible as an opening 1018 in the lower arm 1003 in FIG.10F. FIGS. 10G and 10H show the same views of the suture passers 1001shown in FIGS. 10E and 10F, but with the tissue penetrator 1020 extendedfrom the first (lower) arm 1003. The tissue penetrator may extend in acurved path through the tissue between the first and second arms, asshown. All of the devices shown in FIGS. 10A-10H include a handle 1030.In FIGS. 10G and 10H a control 1031 on the handle 1030 is shown asdepressed, actuating the extension of the tissue penetrator 1018 betweenthe upper and lower arms.

As described, the meniscus repair suture devices described herein may beused to repair longitudinal meniscus tears (e.g., FIG. 5A). Theconfiguration of the arms (which move axially in the long axis of thedevice) and the tissue penetrator element (which is configured to extendsubstantially perpendicular to the lower arm), of the devices describedherein may also be used to repair radial or even oblique tears in themeniscus (e.g., FIGS. 5B-5E). Repair of such tears is typicallydifficult or impossible using other prior art devices. Repair of suchradial and oblique peripheral tears is made possible because the suturepasser described herein may pass suture from the superior (upper) to theinferior (lower) surface of the meniscus (or vice versa). Repair ofradial and oblique tears is also made simpler and more convenientbecause the meniscus suture passer devices described herein maycontinuously pass a suture between the upper and lower arms withouthaving to be removed from the tissue. This is illustrated in FIGS.11A-11 i.

FIGS. 11A-11 i illustrate one variation of a method of repairing aradial meniscus tear using one variation of a meniscus repair suturepasser device as described herein. FIGS. 11A-11B shows the distal end ofa suture passer (the curved/bent distal end of the upper arm of thedevice) 1101 approaching a region of a meniscus having a radial tear1103. The distal tip of the upper arm may be maneuvered to fit within aminimal incision and may follow along the contour of the upper surfaceof the meniscus. Once the upper arm is positioned, the lower arm 1105may be extended under the meniscus, as shown in FIG. 11C. In thisexample, the lower arm is fully extended, and then the tissuepenetrating element is extended through the tissue. The tissuepenetrator may extend through the meniscus and/or through the capsuleregion. In this example, the lower arm is pre-loaded with a sutureattached to a shuttle and held on the tissue penetrator.

In some variations the upper arm is pre-loaded, with the suture andshuttle held in a shuttle receiver/dock at the distal end region of theupper arm. In FIG. 11C, extending the tissue penetrator until it engageswith the shuttle in the shuttle dock on the upper arm causes the shuttleto secure onto the tissue penetrator and be released from the shuttledock. Any appropriate tissue penetrator may be used. For example, thetissue penetrator may be a solid curved needle-like element having atriangular cross-section that engages with the inside of a shuttle“clip” connected to the suture. In this example, the suture and shuttleare initially held on the tissue penetrator (clipped on) and the sutureis pulled through the tissue as the tissue penetrator is extendedthrough the tissue. Once the tissue penetrator engages the shuttlereceiver/dock on the upper arm, it may engage the shuttle receiver andtoggle the dock/receiver to secure the shuttle within the receiver,allowing it to be unclipped from the tissue penetrator.

In general, engagement of the tissue penetrator with the shuttle regionmay toggle engagement or release of the shuttle dock/receiver from theupper arm. This toggling may allow the upper arm to hold or release theshuttle from the dock/receiver; toggling may therefore pre-set thedock/receiver it to either release or receive the shuttle during thenext engagement with the tissue penetrator. Thus, the shuttledock/receiver may have a mechanical “memory.”Alternatively, the shuttledock may be configured so that if it already has the shuttle present itwill release it, and if it does not have the shuttle it will capture itfrom the tissue penetrator. This toggling may be individually controlledfor all of the shuttle docks on the upper arm if more than one ispresent), or it may be collectively controlled. Thus, in some variationseach of the shuttle docks may be loaded with a separate suture, allowingmultiple sutures to be passed without having to remove and re-load thedevice, by using separate shuttle docks/receivers on the upper arm.

Once the suture is passed from the lower arm (via the tissue penetrator)to the upper arm, the tissue penetrator may be retracted back the lowerarm, leaving the shuttle and suture in the upper arm, and the device maybe moved laterally relative to the meniscus, as shown in FIG. 11D.Lateral motion of the distal end of the device across the radial tear,as illustrated, will pull the suture from the lower arm (e.g., where itmay be held loosely within a lumen of the device (e.g., in the lower armor a cannulated region of the device body) and through the tissue tofollow the upper arm. The suture remains attached to the suture shuttle,and therefore follows it as the arms are moved relative to the tissue.The dashed lines show the path of the ends of the device in FIG. 11D.

Generally, the suture may be managed by the device. The suture may beheld loosely within a lumen of the device (e.g., within the upper arm,elongate body region of the device, lower arm, etc.) so that it may befed out of the device and allowed to pass through the tissue easily. Inother variations the suture is not held within the device, but it eitherfreely connected (e.g., hanging from the distal end of the device),partially held within the device, fed through a loop of wire or suturefrom the device, or kept in a track or guide along the outside of thedevice (or some combination thereof). In FIG. 11E, the suture is shownextending from the elongate body of the device. In other variations thesuture may be held in the upper arm, particularly when preloaded in theupper arm. The device (including the upper arm, elongate body, lowerarm, etc.) may include one or more lumen or passages for the suture,which may include exits (e.g., side exits) for managing the pathway ofthe suture as it is passed through the tissue.

Returning to FIG. 11D, once the distal end of the device has beenpositioned on the other side of the meniscus tear, the tissuepenetrating member may again be extended through the tissue (e.g.,through the meniscus, capsule, etc.) where it can again engage with theshuttle and/or suture, causing the shuttle to be disengaged from theshuttle dock/receiver on the upper arm. The shuttle and suture are thencoupled to the tissue penetrator (e.g., by snapping the shuttle onto thetissue penetrator) and the tissue penetrator can be pulled through thetissue, pulling the suture with it though the tissue until the shuttleand suture coupled to the tissue penetrator are withdrawn into the lowerarm, allowing it to be withdrawn, as shown in FIG. 11E.

The resulting suture passes through the meniscus on either side of thetear, and the suture extends across the tear, in the mattress-likestitch shown in FIG. 11E. Thereafter, the device can be withdrawn,leaving the ends of the suture trailing, as illustrated in FIG. 11F,allowing the suture ends to be tied across the tear, pulling the side ofthe torn region of meniscus together, as illustrated in FIG. 11G. Thesuture may be knotted (directly or using a knotting device), and tiedoff. Alternatively, a prettied sliding knot may be provided within thedevice. Thereafter, the less-vascular regions of meniscus (towards thenarrower, more apical region) may be removed, as illustrated in FIGS.11H and 11 i.

In general, the distal end regions of the lower and upper (first andsecond) arms may be configured to form a distal opening by sliding thelower (first) arm distally once the upper (second) arm has beenpositioned on one side, preferably the superior side, of the meniscus.The distal end regions may also be configured so that the tissuepenetrator may be able to extend across the tissue within the distalopening from one or more positions. For example, one schematicillustration of a distal opening formed by the distal ends of the firstand second arms of a suture passer is illustrated in FIGS. 12A and 12B.These examples indicate exemplary dimensions; these dimensions areintended only to provide one illustration of dimensions that may beused. The suture passer devices making up this invention are not limitedto these dimensions.

For example, FIG. 12A shows a lower arm 1205 that is axially movablerelative to the upper arm 1205. A tissue penetrator 1207 may be housedwithin the lower arm completely until it is extended across the distalopening 1211. In this example, the angle between the upper and lowerarms (θ) is approximately 35 degrees. As mentioned above this anglemaybe greater or lesser than 35 degrees by 2 degrees, 5 degrees, 10degrees, etc. but is generally an acute angle slightly greater than thecorresponding angle between the inferior and superior surfaces of mostof menisci. In this example, the overall diameter of the shaft region(proximal to the distal end region forming the distal opening) isapproximately 6 mm. In general, this diameter may be less than 10-15 mm.In FIG. 12A, the tissue penetrator extends near the distal ends of thefirst and second arms, so that the tissue penetrator exist the distalend of the lower (first) arm 1205 and travels in a curved path acrossthe distal opening to pass at least partially into the shuttle dockregion (not visible) near the distal end of the upper (second) arm 1203.In FIG. 12B, the lower (first) arm 1205 is retracted partially in theproximal direction. In this configuration, the tissue penetrator 1207may be extended across the distal opening 1211′ to engage with a shuttledock (not visible) on the upper (second) arm 1203. Thus, as describedabove, by moving the lower arm, the device may make radially differentpathways (and thus suture stitches) through the meniscus, withoutrequiring the device to otherwise move. In this example, moving thelower arm may be considered one way to reposition the device relative tothe meniscus. In FIGS. 12A and 13B, the shaft diameter is approximately6 mm, the distal opening from top to bottom is approximately 12 mm, andthe tissue penetration at the deepest point is approximately 7 mm, asillustrated on the figures.

In general, the tissue penetrators described may be completely retractedwithin one of the arms, typically the distal end region of the firstarm. In some variations, the needle may be curved. In other variationsit may be desirable to have the needle assume a curved shape uponleaving the arm. For example, the needle may be pre-biased or bendableinto a curve that permits it to extend across the distal opening formedbetween the arms in a curve. FIGS. 13A and 13B illustrate one variationof a curved needle (FIG. 13A) that may straighten out when retractedinto the arm, as shown in FIG. 13B. In this example, the needle includesslices 1303 that increase the flexibility of the needle. One side of theneedle is solid 1305, so that the needle retains lateral stability. Theneedle may be formed of a metal (e.g., stainless steel, shape memoryalloys such as Nitinol, etc.). FIGS. 14A and 14B illustrate onevariation of a needle such as the one shown in FIGS. 13A and 13Bretracted into (FIG. 14A) and extending from (FIG. 14B) a lower arm toextend across to the arm forming a distal opening. An axial pushingelement (not shown) may be attached to the proximal (non-sharp) end ofthe tissue penetrator needle to drive it in and out of the lower arm.

FIG. 14C illustrates another variation of a needle that is bendable orcurveable. In this example, the needle is hinged 1403. The pivot pointallows the needle to be collapsed for retraction into the lower law.Multiple hinged regions may be used. In some variations, the needle maybe solid, but may be formed of a shape memory or super/hyper elasticmaterial that assumes the curved shape upon leaving the lower arm.

Any appropriate variation of tissue penetrator and suture shuttle may beused, as mentioned above. FIGS. 15A-20 illustrate some variations ofsuture shuttles and tissue penetrators. For example, FIGS. 15A-17illustrate various embodiments of suture shuttle 70, 170 and 270. Asuture shuttle 70, 170 and 270 may be any shape such that it may bereleasably attached to tissue penetrator 50. While the shape of shuttle70, 170 and 270 may correspond to the shape of at least a portion of thetissue penetrator 50 for attachment purposes, it may be of any suitableshape. In these illustrative examples, the shuttle is generallytriangular in shape, which may correspond to a tissue penetrator 50having a generally triangular cross-sectional shape. The illustratedexamples of suture shuttles are “channel shuttles” which may engage atissue penetrator 50. For example, a triangular or cylindrical tissuepenetrator 50 may be used, as illustrated in FIGS. 18-19D, to which thesuture shuttle 70, 170 and 270 is adapted to connect. Tissue penetrator50 may be, for example, a needle or any like instrument capable ofpuncturing through tissue. Shuttle 70, 170 and 270 may be substantiallyhollow within the triangular shape, and may further have a channel 71,171 and 271, or opening, along a portion of the triangular body. Thischannel 71, 171 or 271 may serve as an entry way for tissue penetrator50 to engage the shuttle 70, 170 and 270. Thus, in these embodiments,the shuttle 70, 170 and 270 wraps around a portion of the tissuepenetrator 50, which is positioned within the body of the shuttle.

For example, in FIGS. 15A-B, the channel 71 may be positioned on anyportion of the shuttle 70. In the illustrated examples, the channel ispositioned along an apex of the triangular shape. However, a channel mayalso be placed along a side of triangular shape or in any otherappropriate place.

Some embodiments of shuttle 170, 270 may also contain openings 74 whichmay make the shuttle lighter, and may also facilitate flexing of theshuttle so that it can readily attach/detach from the tissue penetrator50. Further, opening 74 may provide an area through which a retainingmechanism, such as a retainer pin 30, may pass to secure shuttle 170,270.

Some embodiments of shuttle 70, 170 of the present invention may includeadditional features which may provide controllable, positive, robust,repeatable, and manufacturable retaining structures. Such features mayinclude, for example, protrusions, such as dimples 72, 172 or the like,and finger springs 175 a and b, both of which may help to retain shuttle170 on the tissue penetrator 50.

The protruding dimples 72, 172 may interact with divots 52, 152 locatedwithin a cut-out 51, 151, or recessed portion, of the tissue penetrator50. The dimples 72, 172 allow for controllable, repeatable retaining ofthe shuttle 70, 170 on the tissue penetrator 50, whereby the shuttlemay, in a preferred embodiment, snap on and off the tissue penetratorrepeatedly, as necessary. In a preferred embodiment, the position ofshuttle 70, 170 on the tissue penetrator 50 may be the same given anadditional feature such as the dimples and divots. In an alternativeembodiment, dimples 72, 172 may be located on the tissue penetrator 50,while the divots 52, 152 may be located on the suture shuttle 70, 170.

In a further embodiment, the cut-out 51, in FIGS. 18-19D, may beconfigured to seat the shuttle against the outer surface of the tissuepenetrator, thereby allowing the tissue penetrator to present a uniformouter surface as it penetrates the tissue; meaning the shuttle does not“stick out” from the tissue penetrator, but is flush with the outersurface of the tissue penetrator. This helps keep the shuttle on thetissue penetrator as it extends from upper arm 20 and penetrates tissue.

Additionally, in yet a further embodiment, the upper edge 54 of tissuepenetrator 50 may be sharpened to provide additional cutting surface ontissue penetrator. In this variation, the shuttle 70 should not interactwith the upper edge 54 such that upper edge 54 is exposed to assist inthe piercing action of tissue penetrator.

In a further preferred embodiment, tissue penetrator 50 may include anadditional cut-out 51′ along a portion of tissue penetrator 50 withincut-out 51. Cut-out 51′ may allow additional room for a linkage 85.Cut-out 51′ may reduce the chance of damage to linkage 85 during tissuepenetrator 50 insertion into shuttle 70, since cut-out 51′ may provideadditional clearance for linkage 85.

In one embodiment, for example in FIGS. 16A-B and 19A-D, finger springs175 a and 175 b may interact with a ramp 153 within the cut-out 151 ofthe tissue penetrator 150. The finger springs, and even the entire sidesof the shuttle 170, may be sloped inwardly towards one end of theshuttle. Thus, in this embodiment, the finger springs are located at thenarrowest portion of the shuttle. This slope of the finger springs mayinteract with the slope of the ramp 153 of the cut-out portion 151. Theinteraction of these two slopes may regulate the holding force of theshuttle 170 on the tissue penetrator 150 prior to the dimples 172interacting with the divots 152 to firmly secure the shuttle to thetissue penetrator. Likewise, the holding force is regulated as theshuttle is removed from the tissue penetrator in a similar manner. Thus,when a force is applied to shuttle 170 to pull shuttle 170 off tissuepenetrator 150, the finger springs may be forced along the ramp, towardsthe tip of tissue penetrator, to engage the ramp, causing the fingersprings, and thus the sides of the shuttle, to flex apart from oneanother, and disengage the dimples from the divots.

Continuing with this embodiment, in FIG. 19A, for example, the dimple172 of the shuttle is engaged with the divot 152 on the tissuepenetrator 150. At this point, the finger springs may only be slightlyengaged to the tissue penetrator. FIG. 19B illustrates the shuttle 170beginning to be removed from tissue penetrator. The dimple is no longerin the divot and is instead moving along the surface of the tissuepenetrator. The finger springs 175 a are increasingly engaged onto thetissue penetrator as they move along ramp 153 within cut-out on tissuepenetrator. In FIG. 19C, the finger springs are shown as fully engagedwith tissue penetrator, particularly at the point where the ramp ends(at the distal end of cut-out portion). This full engagement may, in apreferred embodiment, cause the shuttle to flex, and as a result widen,such that the dimples are no longer in contact with the cut-out portionof the tissue penetrator. FIG. 19D illustrates the final step whereinthe dimple and finger spring are no longer touching the tissuepenetrator at all, and the tissue penetrator may be retracted, leavingthe shuttle 170 free.

Thus, in various embodiments, the tissue penetrator may be adapted tomate with one or more elements on the suture shuttle, whether it is adimple, or like protrusion, or finger springs, or the like, that canengage with a divot, depression, cut-out or ramp portion on the tissuepenetrator.

Shuttle 70, 170 and 270 may be made of any material suitable for use insurgical applications. In a preferred embodiment, the shuttle must havestrength, yet also have sufficient flexibility and resiliency to be ableto move on and off the tissue penetrator. Such movement requires theshuttle to flex during removal from and addition to the tissuepenetrator. Thus, a suitable spring characteristic may be achieved witha high stiffness material, such as steel, by designing the spring suchthat it has a high preload characteristic when installed relative to thetolerances. For example, one shuttle design illustrated herein mayinclude retention features that are lower spring stiffness & highpreload, which may help provide more consistent performance and decreasesensitivity to tolerances. Note that the intrinsic stiffness of thematerial (Young's modulus) and the spring constant of the shuttle may berelated, but may not be equivalent. In addition, these shuttle designsmay have significantly reduced tolerance sensitivity, wherein thetolerance is a small percentage of deflection, compared to other shuttledesigns. One suitable material may be stainless steel. For example, theshuttle may be composed of 0.004 in. (0.01 mm) thick 17-7 PH stainlesssteel, Condition CH-900.

Shuttle 70 may be made of material whose hardness is matched to thetissue penetrator 50. Tissue penetrators of a material that is too hardrelative to the shuttle may wear out the shuttle. In one example, thetissue penetrator is stainless steel, Rockwell 60C hardness. The shuttlethen may be precipitation hardened stainless steel, “17-4 PH”, which isalso known as stainless steel grade 630. The shape of the shuttle ismatched to the shape of the tissue penetrator, and the shuttle clipsonto a portion of the tissue penetrator, and can be slipped on and offrepeatedly.

The shuttle 70 may be made of a material having a hardness, stiffnessand elasticity sufficient so that it may partially elastically deflectto clamp onto the tissue penetrator 50. In particular, we have foundthat matching the hardness of the shuttle to the hardness of the tissuepenetrator may be particularly important for repeated use. For example,the shuttle may be made of Nitinol, beryllium copper, copper, stainlesssteel, and alloys of stainless steel (e.g., precipitation hardenedstainless steel such as 17-7 PH stainless steel), cermet (ceramic andmetal), various polymers, or other biocompatible materials. The materialchosen may be matched to the material of the tissue penetrator forvarious properties including, for example, hardness and the like. Theshuttles may be formed in any appropriate manner, including punching,progressive die, CNC, photolithography, molding, etc.

In the above examples, a pull-out force, or the force required to removethe shuttle 70 from the tissue penetrator 50, may be more than about 2pounds of force. Preferably, the force may be about 2 to about 5 pounds.The force may be from, for example, the pulling of a suture, or sutureclip or connector, attached through one of the bore holes 73 located onshuttle 70. This force should be from the direction of about the tip ofthe tissue penetrator.

In a preferred embodiment, illustrated in FIGS. 15A-B, the bore holes 73are located away from channel 71 and towards the base of the triangle,which may be in a fold in the shuttle, as shown in FIG. 5B. In the otherillustrated embodiments, FIGS. 6A-7 for example, the bore holes 173 areadjacent the channel. FIGS. 15A-B illustrate a position of bore holes 73which may reduce, or even eliminate, the bending forces on the sides ofshuttle 70, when suture, or the like, applies a force at bore holes 73.Typically, when bore holes 73 are located adjacent channel, as in FIG.6A, the bending force on the side of the shuttle may peel the shuttlefrom the tissue penetrator 50 at a force lower than the desired removalforce, due to the advantage of the force being applied to a corner ofthe shuttle 70. However, bore holes 73 located as shown in FIG. 5Blimits this bending force, or torque, and thus prevents removal ofshuttle 70 from tissue penetrator 50 at a premature time and at a forceless than is desired for removal of shuttle 70.

In another embodiment, the shuttle 70 may be in the shape of a spiraledwire, or the like, such as a “finger torture” type device, whereby asthe shuttle is pulled by the tissue penetrator 50, the shuttle maytighten around, thereby securing itself to the tissue penetrator. Thestronger the force of the pull, the tighter the spiraled wire secures tothe tissue penetrator. When the shuttle is to be transferred from thetissue penetrator, for example, to the shuttle retainer seat 25, theshuttle may be twisted, or the like, to “unlock” the shuttle from thetissue penetrator.

Other examples of shuttles 70, which may be able to clamp onto thetissue penetrator to secure itself, may be torsion springs, snap rings,a portion of wire, elastically deformable shapes, conically taperedshapes, and the like. Elastically deformable shapes may be any shapedesired, such that it can be deformed to wrap around at least a portionof the tissue penetrator. Useful shapes may include, but are not limitedto, cylinders, triangles, overlapping rings, and any partial portion ofa shape such as a semi-circle. Once the tissue penetrator is inposition, the shape of the tissue penetrator receiving area allows theelastically deformable shape to return to its original configurationwhile being securely attached to the tissue penetrator. Of course, thecut-out 51, or recess, or receiving area, on the tissue penetrator mayin a preferred embodiment be shaped such that it coincides with theshape of the shuttle. For example, if a conically tapered shuttle wereused, the tissue penetrator may include a conically tapered cut-out on aportion of the surface. The conically tapered shuttle may be deformable,and may deform upon being moved into the cut-out. Once completely withinthe cut-out, the conically tapered shuttle would return to its originalshape and secure itself within the cut-out. The cut-out may include, forexample, a lip, or the like, to assist in securing the shuttle, fully orpartially, within the cut-out.

In other embodiments, the shuttle may constitute the tip of the tissuepenetrator 50 itself, as illustrated and described below in reference toFIGS. 21A-22B, such that the tip may be releasably coupled on the end ofthe tissue penetrator. Thus, the tip of the tissue penetrator may bepassed between distal opening formed by the distal end regions of thearms of the suture passer device, and to pass the suture (attached tothe tip), back and forth through the tissue.

Suture 90 may, in one embodiment, be attached directly to shuttle 70 atbore hole 73, or other like retention location. Of course, suture neednot be secured only by a bore hole. Instead, suture may be secured toshuttle by adhesive, a clamp, by being ties or engaged to a portion ofthe shuttle, or in any other suitable manner.

Additionally, suture 90 may be secured to shuttle 70 via an intermediarydevice, such as the examples shown in FIG. 20. One such intermediarydevice may be a suture clip, loop, or suture retainer 80. A suture clipallows for simple and efficient releasable connection of a suture to ashuttle. A suture clip may be used for continuous suture passing, oralternatively for single passing of a suture.

In operation, suture clips 80, such as the example illustrated in FIG.20, may be used as part of a system for suturing tissue, particularlywhen used with a continuous suture passer 10. For example, a suture 90may be passed from the second arm 20 to the first arm 21 and/or backfrom the first arm to the second arm of a suture passer. This may beaccomplished using an extendable tissue penetrator 50 that is connectedto the first arm, as described above. The extendable tissue penetratorcan pierce the tissue, and can also engage a suture shuttle 70, to whicha suture is attached through the suture clip 80, loop, or otherattachment. The suture may then be pulled through the passage that thetissue penetrator forms in the tissue. Extending the tissue penetratorforms a passage through the tissue, which may also pass the suturebetween the opening formed between the distal end regions of the firstand second arms. For example, the tissue penetrator may include a sutureshuttle engagement region which may be, for example, a cavity within thetissue penetrator, along the outside of the tissue penetrator, or thelike, to which the suture shuttle can be releasably attached. The suturecan be passed from the tissue penetrator in the first arm to or from asuture shuttle retainer seat 25 connected to the second arm. Thus, boththe tissue penetrator and the suture shuttle retainer seat (shuttledock) may be configured to releasably secure the suture, which may beattached to a suture shuttle.

In some variations, the suture clip 80 described herein may include anattachment linkage 85 to a suture shuttle 70, for example a tether,leash, lead wire, or the like, which may be configured to connect thesuture clip to the shuttle. In some examples, the suture clip includes abias, for example, a spring, for securing a linkage 85 within a snap-fitelement. Alternatively, the suture clip may include a central openingthrough which a linkage may be threaded. This linkage can act as aspacer. In one embodiment, the linkage may be stiffly attached to theshuttle 70 such that it both spaces the shuttle from the suture and alsocontrols the position of the shuttle based on a force exerted on thelinkage. The linkage will also control the position of the suture as theshuttle is passed from one arm to the other.

Similarly, the linkage 85 may be a stiff metallic wire, a portion ofsuture, a flexible polymeric strand, or the like. In the example of astiff metallic wire, the wire may be welded to the shuttle such that itmay project from the shuttle in a predictable manner.

In one embodiment, illustrated in FIG. 20, the shuttle 70 may beconnected to a suture clip 80 that may be a compressed loop, in whichthe compressed loop has an inner, generally “teardrop” shaped opening 86that is wider in one end than the other. The suture 90 may then bethreaded through the inner loop 86 such that it becomes wedged withinthe narrow portion of the teardrop shape. The suture may then be securedby any method known in the art such as by tying a knot or bringing theend outside of the body. The suture may also be secured solely by beingwedged within the teardrop shape, which may be sufficient to secure thesuture within the suture clip.

FIGS. 21A-22B illustrate examples of tissue penetrators in which asuture shuttle 2101 forms the distal tip of the tissue penetrator. Forexample, in FIG. 21A, the suture shuttle is an approximately three-sided(pyramidal) tissue penetrating suture shuttle that include a pointeddistal tip. This tissue penetrating suture shuttle fits over the distalend region of the tissue penetrating element, as shown in FIG. 21A. Thetissue penetrating suture shuttle is shown disengaged in FIG. 21B.

FIG. 21C shows an enlarged view of the distal tip 2105 of the tissuepenetrating element of FIG. 21A and 21B, to which the tissue penetratingsuture shuttle (not visible in FIG. 21C) releasably secures. As isapparent in FIG. 21C, the sides of the distal tip region of the tissuepenetrating element include one or more detents (projections) 2107 thatmay snap into and engage corresponding regions within the tissuepenetrating suture shuttle (not shown). Thus, even without the tissuepenetrating suture shuttle, the distal end of the tissue penetratingelement in this example is also tissue-penetrating. In some variations,the distal end is not tissue-penetrating, but may be flattened, rounded,blunted, etc. In some variations, the distal end may be keyed tomechanically interlock with the internal portion of a tissue penetratingsuture shuttle.

In some variations, the distal end of the tissue penetrating elementincludes one or more recesses into which a projection from the tissuepenetrating suture shuttle extends.

The variation shown in FIGS. 21A-C allows the tissue penetrating sutureshuttle to snap onto the distal end of the tissue penetrating member.Friction, or the elastic deformation of one or more detents, buttons,knobs, nubs, projections, etc. may be used to hold the tissuepenetrating suture shuttle onto the tissue penetrating element. In somevariations, the tissue penetrating suture shuttle is actively secured tothe tissue penetrating element. For example, a tissue penetratingelement may include a magnetic or electromagnetic element that grasps orsecures the tissue penetrating suture shuttle to the distal end regionof the tissue penetrating element. In some variations the tissuepenetrating suture shuttle is held on the tissue penetrating element bya vacuum or other member. In some variations, a bar or other member maybe extended from the tissue penetrating element to engage with a site onor within the tissue penetrating suture shuttle to lock it in position.The lock may be deactivated or withdrawn (e.g., by withdrawing a bar) inorder to release the tissue penetrating suture shuttle form the tissuepenetrating element.

FIGS. 22A-22B illustrate another variation of a tissue penetratingsuture shuttle and tissue penetrating element. In this variation, thetissue penetrating suture shuttle includes both a pointed distal end,but also includes an elongate cutting side (the bottom surface 2205,2205′). The tissue penetrating element is also pointed at the distalend, and this end of the tissue penetrating element fits into the tissuepenetrating suture shuttle. For example, FIGS. 22A shows the tissuepenetrating suture shuttle attached to the distal end of the tissuepenetrating element. FIG. 22B shows the tissue penetrating sutureshuttle disconnected from the tissue penetrating element.

In some variations the meniscus repair suture passer device isconfigured to pass a suture back and forth through tissue withoutrequiring a shuttle. For example, the tissue penetrator may beconfigured to releasably connect directly to a suture. A tissuepenetrator may include a suture engagement region (e.g., at or proximalto the distal tip of the tissue penetrator) that holds the suture untilit is released into a dock on the opposite arm of the device. Forexample, the tissue penetrator may include a hook (with or without alatch) into which the suture may be held. In some variations the tissuepenetrator includes a clamping or gasping mechanism (e.g., one or moreclamping surfaces on the tip or side of the tissue penetrator) forsecuring the suture until it can be released into the dock on theopposite arm. Similarly, the dock (which may be present on the second orupper arm in some variations), may be adapted for directly securing thesuture to the arm opposite from the arm connected to the tissuepenetrator. A suture dock may be modified from the shuttle docksillustrated above, and may include a hook, clamp, gasper, or othermechanism for alternately securing the suture and releasing it onto thetissue penetrator. The dock may also include an exchange mechanism forde-coupling the suture from the tissue penetrator (e.g., releasing alatch in variations having a latch, unclamping a clamp, etc.). Thus, thedock may be configured to alternately engage and disengage the suturefrom the tissue penetrator and thereby release or retain it in the dock.In some variations the device may be configured to pass a suture fromthe second arm (where it may be pre-loaded into the dock) to the firstarm (via the tissue penetrator) and then back to the second arm (againvia the tissue penetrator) and released back into the dock; thuscompleting two passes through the tissue, which may be in differenttissue locations, since the device may be repositioned between passes.In some variations additional passes through the tissue may becompleted, or the device may be configured for just two passes (aforward and backward stitch).

In practice, the procedure may begin with a 5-10 mm skin incision at theanterior knee through which an arthroscopy camera is inserted. The kneemay then be distended with saline in typical fashion. A camera may bemoved into position such that the meniscus tear can be clearlyvisualized. Varus or valgus stress may be placed across the knee to openup the joint space in typical fashion. FIG. 23 illustrates the anatomyreferred to herein.

The meniscus repair suture passer device may then be inserted throughanother 5-10 mm incision created in the skin at the anterior knee. Suchincisions are used for typical or accessory knee arthroscopy portals.The distal end of the device traverses the skin and enters the fat padin the anterior compartment (see arrow 2305). Gentle pressure allows thedevice to slide though the fat pad and into the space between the femurand tibia. The surgeon may choose to lower his/her hand as the curved orbent distal end of the upper arm follows the curvature of the femoralcondyle allowing access to the posterior or peripheral knee. The distalend region of the upper arm is then positioned approximated above themeniscus tear. In some embodiments the superior capsule may be pushedperipherally with the distal aspect of the upper aim to allow themeniscus apex to flex superiorly (illustrated in FIG. 24A-24C), thusaiding in later extension of the lower arm beneath the meniscus. Thelower arm is then extended distally underneath the meniscus to bepositioned.

For example, in FIGS. 24A-24C, the tip of the upper arm is used to applyoutward pressure on the capsule just superior to the peripheral meniscustissue. In doing so, the central aspect of the meniscus 2405 flipsupward a few degrees allowing easier access for the lower arm to slideunder (inferior) to the meniscus. This may allow easier exposure for thelower arm to slide under (inferior) to the meniscus and, may also permita deeper (larger) “bite” of tissue to be obtained during the initialpass, thus more tissue can be incorporated into the repair.

In these variations, the suture may pass through both meniscus andadjacent material, all while preventing damage to vascular structuresfeeding the meniscus and surrounding/supporting structures. For example,peripheral tissue may be captured within the distal opening formedbetween the upper and lower arms of the device in a way that the suturepathway (following the tissue penetrator) arcs through the capsulebehind (peripheral) to the tear during the first few needleadvancements/shuttle exchanges and a second pass may then go through themeniscus tissue itself. Passing in this manner may capture the repairtissue in a way that is optimal for repair and has no risk of damagingthe common peroneal nerve or popliteal artery. The arching first pass ofthe device may allow the capture and repair of more tissue withoutdeleteriously plunging into the back of the knee.

Any of the variations of the suture passers described herein may alsoinclude suture guides, channels or controls to direct the suture as itis passed through the tissue. The suture channels may be open or closed,and may be cavities or channels that are formed within the arms, tissuepenetrator(s) and intermediate regions of the device. The channels maybe coated or formed to reduce friction or regions that the suture maycatch or tangle on. Control of the suture may be important to theworking of any of the devices described herein.

As mentioned above, the suture passers described herein may also beconfigured as dual deployment suture passers, because the tissueengaging region of the suture passer comprises a distal-facing openingformed between two jaws (a first jaw member and a second jaw member),and each jaw member may move (may be deployed) independently with adifferent type (e.g., axis, plane, range, etc.) of motion. Many of thedevices described herein may also be referred to as clamping/slidingsuture passers, because the one of the jaw members may clamp onto thetissue, by changing the angle of the jaw member relative to the moreproximal elongate body region of the device, and the opposite jaw membermay slide, moving axially relative to the more proximal elongate bodyregion of the device.

FIGS. 25A-25B show a generic version of a dual deployment suture passer.FIG. 25A shows a suture passer having a second jaw member in a retractedstate; FIG. 25B shows the same suture passer with the lower jaw in anextended state. This generic schematic of a dual deployment (e.g.,clamping/sliding) suture passer may be used to illustrate operation ofthe device in different tissues.

As discussed above, any of the devices described herein may beconfigured so that the tissue penetrator may extend distally from thedistal end of one of the jaw members. Thus, in some variations, a tissuepenetrator includes a mouth that opens in a distal-facing direction. Themouth is formed from a first jaw (e.g., upper jaw) and a second jaw(e.g., lower jaw); the tissue penetrator may extend between the firstand second jaw in an approximately sigmoidal pathway. This isillustrated in FIGS. 26A-26C.

FIGS. 26A-26C show a schematic of one variation of a tissue penetratorhaving a distal-facing mouth 3201. The tissue suture passer has beenmade semi-transparent to show the tissue penetrator 3203 within thelower jaw member in FIG. 26A. In this example, the suture passer isconfigured so that the tissue penetrator may be extended distally first(in FIG. 26A) through the lower jaw member 3205 until it is deflectedout of the lower jaw and across the distal facing mouth 3201. In thisexample, the lower jaw includes a deflector 3213 that redirects thetissue penetrator out of the lower jaw and towards the upper jaw, asshown in FIG. 26B. The tissue penetrator may pass through any tissueheld within the open mouth 3201, and eventually meet the upper jawmember 3207. Once within the upper jaw member 3207, the tissuepenetrator may then be deflected so that it extends distally within theupper jaw member. As shown in FIG. 26C, the tissue penetrator 3203 maybe deflected distally by an internal deflector 3209 within the upper jawmember 3207. The tissue penetrator 3203 may extend distally out of adistal opening 3211 at the distal end of the upper jaw member 3207.

Although many of the suture passer variations configured for sigmoidalmovement of the tissue penetrator, in which the tissue penetratorextends distally from a jaw member, may be configured as dual deploymentsuture passers (e.g., in which the two jaw members move independentlywith different types of motion), suture passers with fixed jaws orsuture passers in which only one jaw moves relative to the suture passermay be used. For example, FIGS. 27A-27F show three different variationsof suture passers having a distally extending tissue penetrator thattravels in an approximately sigmoidal path.

For example, in FIG. 27A the upper and lower (first and second) jawsforming the distal-facing mouth of the suture passer are both movable,as described above for the dual deployment configuration. The tissuepenetrator 3304 is shown extending from the lower jaw member 3303,across the distal-facing opening, and into the upper jaw member 3306,where it then extends distally slightly beyond the distal end of theupper jaw 3306. The suture passer of FIG. 27A is also shown in FIG. 27B,illustrating the movement of the upper and lower jaw members. Asindicated in FIG. 27B, the upper jaw 3306 can pivot 3315 around a hingepoint 3311 at the distal end region of the elongate member 3308. Thelower jaw member 3303 can move axially (proximally and distally) 3317relative to the elongate member 3308.

In FIGS. 27C and 27D, only one of the jaw members (the upper jaw member)may move; the opposite jaw member is fixed. In FIG. 27C, similar to FIG.27A, the tissue penetrator extends distally from the upper jaw member3306 out of a distal opening (not shown), along a sigmoidal path. Asshown in FIG. 27D, the upper jaw includes a hinge point 3311 so that itcan be controllable pivoted 3327 (using a proximal control) to form anangle with respect to the distal end region of the elongate shaft.

In FIGS. 27E and 27F, the upper jaw is shown as fixed (e.g., in apre-formed bend or angle relative to the distal end of the elongatemember) and the lower jaw may be moved axially distally/proximally 3337.

The path taken by the tissue penetrator may be approximately sigmoidal,as illustrated in FIGS. 28A-28E. FIG. 28A illustrates the differentpaths for a tissue penetrator in a suture passer having an upper jawmember that pivots. In any of the angled positions shown the suturepasser may take an approximately sigmoidal path. FIGS. 28B-28Eillustrate different sigmoidal paths for the tissue penetrator. Ingeneral the term sigmoidal path should be understood to be approximatelysigmoidal when viewed in profile, as shown in FIGS. 28B-28E. In theseexamples the distal end of the tissue penetrator may extend distally atapproximately the same angle as the upper jaw member (as indicated bythe arrows to the left of each of FIGS. 28B-28E), rather thanhorizontally and parallel to the lower jaw member, as in a completelysigmoidal path. FIGS. 29A and 29B show one variation of a tissuepenetrator from a top (FIG. 29A) and side (FIG. 29B) view. The distalend region of the tissue penetrator includes a suture retainer region3505 configured as a hook.

In general, the needle width may be between 0.1″ and 0.02″. For example,in some variations the needle is approximately 0.058″ in width. Theneedle may be relatively thin, e.g., having a thickness between about0.02″ and about 0.005″. For example, in some variations the needle isapproximately 0.0115″ thick. In some variations the needle has athickness of about 0.008″. In general, the needles described herein havesufficient column strength to push through the tissue, and can be bentor deflected with sufficiently low force to accomplish the sigmoidalbend described herein; these needles may also have sufficient fatiguelife to withstand multiple (e.g., 5×, 10×, 20×) extensions andwithdrawals between the upper and lower jaw members and out of thedistal opening in the upper jaw member.

FIGS. 30A-30E illustrate another variation of a dual deployment suturepasser having a tissue penetrator that is configured to travel in asigmoidal path and extend distally from a distal opening in the distalend of the device. In this variation, the upper jaw may pivot and thelower jaw extends distally/proximally in the axial direction. A suture(not shown) may be loaded in the upper jaw so that it may be captured bythe suture passer and pulled back through the tissue down to the second(lower) jaw member, as described in FIGS. 16A-16C, above. In FIG. 30A,the suture passer is shown in an un-deployed state, with the pivotingupper jaw member 3601 at a 45° angle relative to the long axis of theelongate body 3603. As discussed above, in practice the device may beeasily inserted into the tissue and adjacent to the target tissue, andthe angle of the upper jaw member may be adjusted to help position thedevice. In this variation the upper jaw is relatively flat (e.g., has anarrow profile). As seen in FIGS. 30A-30E, the upper member is radiused,and curves relative to the long axis of the device, away from the lowerjaw member 3605.

In FIG. 30B, the lower jaw 3605 has been extended distally from thedistal end of the elongate body. In FIG. 30C, the upper jaw member hasbeen pivoted downward (“clamping” down) so that the angle relative tothe long axis of the elongate body is approximately 30°, and the tissuepenetrator 3607 is being extended from the lower jaw 3605 and across thedistal-facing mouth to the upper jaw, as also shown in FIG. 30D. Thetissue penetrator finally extends distally from the opening 3611 at thedistal end of the upper jaw 3601 as shown in FIG. 30E.

FIGS. 31A and 31B show side and top perspective views, respectively, ofone variation of such an upper jaw member. This variation is similar tothat shown in FIGS. 30A-30E, and allows loading of a suture on the upperjaw member as previously shown in FIG. 16A-16C. In FIGS. 31A and 31B,the upper jaw member includes a deflection surface 3703 and a distalopening 3705 out of which the tissue penetrator (not shown) may exitdistally. The upper jaw shown in FIGS. 31A to 31B also includes a sutureloading region 3711 into which one or more sutures may be threadedand/or preloaded so that they may be engaged by the tissue penetratorand pulled from the upper jaw to the lower jaw. In this variation thesuture loading region is a channel that is adjacent to the deflectionsurface 3703. A tensioning element (not shown) may be used to hold thesuture in the loading region. The tensioning element may be on the upperjaw member, or it may be located more proximally, including on theproximal handle. The tensioning element may be configured to pinch orbind the suture to hold it in position (and in tension) so that it canbe engaged by the suture retainer region on the tissue penetrator.

FIGS. 32A and 32B illustrate another variation of the upper jaw memberof a suture passer, in which the upper jaw member includes a suturestripper for removing (stripping) the suture off of the suture retainerregion of the tissue penetrator and holding the suture (or a loop orbight of suture) in the upper jaw. In FIG. 32A, the upper jaw member3801 includes a deflector region 3803 that is formed, in part, from thesuture stripper 3805. The stripper is formed of a flexible material(e.g., a metal, polymer, or other material, including shape memoryalloys) that can be resiliently deflected to allow the tissue penetratorto pass and extend distally from the distal opening 3809, whilestripping the suture off of the tissue penetrator and holding the suturein the upper jaw. This is described in more detail below. In FIG. 32A,the suture stripper is configured as a leaf-spring structure that issecured to the upper jaw member at the proximal end and the opposite endis free and held in tension against a distal surface of distal openingat the distal end of the device; the tissue penetrator may push againstthe stripper and past it, forcing a suture held in the tissuepenetrator's retainer region against the stripper. As the tissuepenetrator is withdrawn, the suture may be pinched against the stripperand the upper jaw, holding it in place while allowing the tissuepenetrator to be withdrawn. In some variations the end of the stripperand/or the distal opening includes an edge (e.g., having serrations,teeth, etc.) to hold the suture as the tissue penetrator is withdrawn.

FIGS. 33A-33C illustrate one variation of a suture passer having atissue penetrator that extends distally from a distal opening in theupper jaw. The tissue penetrator travels in a sigmoidal path from thelower to upper jaw. In this variation, two lengths of a suture(including two lengths of the same suture, e.g., two ends of the samesuture) can be loaded into the lower jaw and sequentially passed fromthe lower jaw, through different regions of the tissue and retained inthe upper jaw, to pass a loop of suture through the tissue. The suturepasser show in FIGS. 33A-33C is also configured so that the upper jawmember can pivot to assume a different angle relative to the elongatebody of the device, and the lower jaw member is axially extendabledistally from the distal end of the elongate member to form adistal-facing mouth with the upper jaw member. The proximal handleincludes a plurality of controls for controlling the pivoting of theupper jaw member, the axial sliding of the lower jaw member, and theextension/retraction of the tissue penetrator from the lower jaw member.

FIG. 33B shows the device of FIG. 33A with the outer housing of theproximal handle 3901 removed, revealing some of the connections betweenthe controls and the device. In FIG. 33B, the distal most control 3905,the proximal handle is configured as a trigger or lever that controlsthe motion of the upper jaw member (“upper jaw control”). The upper jawcontrol may be pulled to reduce the angle of the upper jaw relative tothe long axis of the elongate member 3907. In this variation the upperjaw control is pinned and allowed to drive a tendon in the elongatemember distally when compressed to drive the upper jaw down (reducingthe angle between the upper jaw and the long axis of the elongatemember). This pivoting motion may also be referred to as scissoring(scissoring motion).

A distal control 3913 is also configured as a lever or trigger, and maybe squeezed or otherwise actuated to extend and/or retract the lower jawto form a distal-facing mouth with the upper jaw, as shown in FIGS.33A-33B. In some variations the control is further configured to controldeployment of the tissue penetrator in the sigmoidal path. For example,in some variations squeezing the distal control after completelyextending the lower jaw may deploy the tissue penetrator from the lowerto the upper jaw so that the distal end of the tissue penetrator extendsout of the upper jaw. As it extends between the upper and lower jaw, thetissue penetrator may carry a first length (bight) of suture through thetissue. Upon reaching the opposite jaw member, the suture may be removedfrom the tissue penetrator and held (e.g., by a stripper) in the upperjaw. Upon release of the distal control, the tissue penetrator maywithdraw back into the lower jaw. Actuating (e.g., squeezing) the distalcontrol 3913 again may result in the extending the tissue penetrator(along with any second length of suture) back through the tissue fromthe lower jaw to the upper jaw, where the second length of suture can beretained. Alternately, in some variations, the controls (e.g., tocontrol motion of the upper and/or lower jaw) may be separate from eachother, and/or from extending/withdrawing the tissue penetrator.Additional controls may also be included in the proximal handle, includea suture loading control (e.g., switch, toggle, etc.) for loading and/ortensioning the suture within the lower jaw member.

FIGS. 34A-34D show an enlarged view of the distal end of the device ofFIGS. 33A-33C. For example, in FIGS. 34A and 34B the upper jaw 4003 isthin and slightly radiused (e.g., curved), and is hinged to the elongateshaft region of the device. The upper jaw is also connected to a control(handle, etc.) on the proximal handle by a push/pull member (tendon,wire, rod, etc.), allowing adjustment of the angle of the upper jawmember relative to the elongate member.

In FIG. 34C, the upper and lower jaw members have been removed from thedistal end of the device shown in FIG. 34B, revealing the tissuepenetrator 4007 within the lower jaw and the stripper 4009 in the upperjaw. FIG. 34D shows the distal end of the device of FIG. 34B after thetissue penetrator has been extended across the distal-facing mouth.FIGS. 36A and 36B illustrate one variation of an upper jaw region havinga suture stripper. In FIG. 36A, the suture stripper is visible from thedistal opening at the distal end of the jaw member. In this example, thestripper includes a stripper plate 4203 with a sawtooth edge 4205. Thejaw member also includes a receiver region for the stripper plate havinga sawtooth edge 4207.

FIGS. 35A-35C show greater detail on one variation of a suture stripperthat may be used. This variation is the same as the variation shown inFIGS. 36A and 36B. Although the examples provided herein show the suturestripper in the upper jaw member, in some variations a suture strippermay be present on the lower jaw member (e.g., where the tissuepenetrator is configured to pass a length of suture from the upper jawto the lower jaw). In FIG. 35A, the stripper includes a flexible plate4101 that is fixed at the proximal end (e.g. to the upper jaw member),and pressed against a receiving plate 4103 at the distal end 4105. Insome variations the receiver is not a separate receiving plate, butmerely a region of the jaw member. Either or both the suture stripperplate 4101 and the receiver 4103 may include an edge that is adapted tocatch the suture. In FIGS. 35A-35C, both the plate 4101 and receiver4103 include edges having teeth 4105 and 4107. In this example the teethare saw-tooth structures that are adjacent (or abutting) in the upperjaw member. The tissue penetrator may pass between the plate 4101 andthe receiver 4103 by deflecting the plate 4101; as the end of the tissuepenetrator passes the edges 4105 and 4107, a length of suture held bythe tissue penetrator may be caught by the stripper and held between theplate and receiver as the tissue penetrator is withdrawn.

Although many of the variations of the devices illustrated above includeinternal deflection regions for directing the shape of the path taken bythe tissue penetrator, the deflection regions may be external orpartially external. For example, in some variation the tissue penetratorextends distally beneath the upper jaw, rather than entering into theupper jaw; a suture may be picked up and/or dropped off in the upper jawfrom this external position.

In general, the devices described herein may be sized and configured toeasily insert to repair tissue into even difficult to access regions,including joint regions such as the knee, shoulder and hip. As mentionedabove the upper and/or lower jaw may be relatively thin. For example, insome variations the upper jaw thickness, which may also be referred toas the height of the upper jaw, may be less than about 0.120 inches(e.g., less than 0.1 inch, less than 0.08 inches, less than 0.07 inches,less than 0.06 inches, etc.). In some variations the height or thicknessof the upper jaw is between about 0.064″-0.120″. FIGS. 37A-37Cillustrate variations of the upper jaw having different heights orthicknesses. For example, in FIG. 37A, the upper jaw member has amaximum height of approximately 0.120 inches. In this variation theupper jaw member includes a limiter that limits the extension of thetissue penetrator from the upper jaw. In FIG. 37B the upper jaw memberhas as maximum height of approximately 0.085 inches, and is curved. FIG.37C shows another variation of an upper jaw member having a maximumheight of approximately 0.064 inches. As shown, any of these variationsmay also be curved, and may be hinged and/or pivotally connected to anelongated member extending from a handle.

The width of the jaw member (upper and/or lower) may be greater than theheight/thickness of the jaw member. In some variations the jaw memberhas a width that is more than twice its height (e.g., between about 0.4and about 0.1 inches). The width may be less of a constrainingdimension, as there may be sufficient space in the joint from side toside; the size constraint may be the space from top to bottom (height)in joints such as the knee.

As discussed above, any of the devices described herein may include anupper jaw that is adapted to fit within the confines of a joint such asthe knee. For example, the upper jaw, which may be hinged relative to anelongate body of the suture passer, as described above, may be radiused(e.g., curved) upwards slightly, particularly over the proximal regionof the upper jaw, near the hinge connection. FIG. 38A illustrates onevariation of an upper jaw that is radiused, having an upwards curvature4815 on the outer/upper surface. In the context of the knee joint, thisupper jaw member (which may also be referred to as an upper jaw or upperarm) may match the curvature of the femoral region of the jointsurrounding the meniscus (femoral condyle).

Thus, the upper jaw of a suture passer adapted for passing suture in theknee around the meniscus may be shaped for joint access such that thesuperior (upper) surface of the upper jaw is radiused to have a gentlecurve that approximates the curvature of the femoral head, as shown inFIG. 38A. An upper jaw with this shape can be easily inserted into theknee joint space so that the upper jaw is superior to the meniscus inorder to facilitate suture passing. However, one potential disadvantageof an upper jaw with the shape shown in FIG. 38A is that the convexsurface on the inferior side (inner, tissue-contacting surface) may havehelp push the meniscus distally out of (and away from) the distal-facingopening between the jaws when the upper and lower jaws are closed overthe meniscal tissue. This may be disadvantageous when trying to pass atissue penetrator (e.g., needle) through the meniscus in a precisemanner, as it can cause the meniscus to be displaced out of the jaws,and/or may cause the needle to miss the suture retention feature in theupper jaw.

Although this issue may be addressed, at least in part, by the relative(including conjugate) motion of the upper and lower jaws describedabove, a modified version of the upper jaw, having a flat or less curvedinferior (tissue-contacting) surface may also address this issue. Forexample, FIG. 38B shows an upper jaw having a geometry with a straighterprofile 4813 in its proximal region (near the hinge). The proximallystraight variation shown in FIG. 38B may have a significantly lowerpropensity for pushing the meniscus out of the distal-facing mouthformed by the upper and lower jaws when the closing the jaws around thetissue, which may help keep the meniscus from being displaced whenpassing a suture with the device, improving locational precision andsuture capture reliability. Unfortunately, this configuration may not beoptimally shaped for joint access, because of the overhead constraint ofthe femur and the lower “slope” of a straight upper jaw. Thus, thedistal tip of the upper jaw may be less able to clear the meniscus onthe superior side as easily as the radiused outer surface. Thedifferences between the proximally curved upper jaw of FIG. 38A and theproximally straight upper jaw of FIG. 38B are shown in FIG. 38C, showingboth upper jaw geometries overlaid on top of each other. In FIG. 38B,the superior surface of the straight upper jaw 4803 is opposite theinferior curved surface of the radiused 4805 upper jaw. When looking atthe overlay, the superior surface of the proximally straight upper jawvariation may contact the femoral head sooner than the superior surfaceof the proximally curved jaw variation. However, when the proximallystraight jaw variation contacts the femoral head, its distal end is notas high, and may have less ability to clear a tall meniscus.

FIG. 38D shows a side view of a hybrid upper jaw having both aradiused/curved proximal superior surface 4815 and a straight (or lesscurved relative to the superior surface) inferior, tissue-contactingsurface 4813. In this example, the upper jaw has a thinner proximalregion (between the hinge 4819 and the distal region 4820.

The hybrid upper jaw shape adapts the proximally radiused superiorsurface with the relatively straight inferior (lower) surface; using theprofile of the curved upper jaw shown in FIG. 38A for the superiorsurface and the distal half of the inferior surface, and the inferiorprofile of the proximally straight upper jaw shown in FIG. 38C. Thishybrid profile combines the excellent access shape along with thefeatures necessary to mitigate the probability that the meniscus ispushed peripherally during clamping.

Thus, any of the suture passers described herein may have hinged upperjaw extending in a proximal to distal axis, with a hinge region at ornear the proximal end. The upper jaw may have an outwardly curved(radiused) superior surface extending distally from the hinge region.The inferior, tissue-contacting, surface opposite this outwardly curvedsuperior surface may be configured to extend straight in the proximal todistal axis. Thus, the thickness of the upper jaw as it extends from thehinge region distally may be narrower (thinner) more proximally thandistally, as shown in FIG. 38D.

Another example of a second arm extending distally from the elongatebody having a radiused upper surface with a radius of curvature ofbetween about 0.5 cm and about 20 cm that curves away from the long axisis shown in FIGS. 39A-39C. As shown in FIGS. 38A-38-D, the arm may behinged to the elongate body to pivot relative to the elongate body, andalso includes a relatively flat lower surface with a radiused uppersurface, so that the resulting thickness of the jaw member varies overthe length of the jaw from a proximal thickness (near the hinged region)to a thinner intermediate region and an overall thicker region at distalend. In FIGS. 39A-39C the distal region also includes a suture trap orcapture region (also referred to as a suture stripper) that includes abiased member (e.g., leaf-spring) to pinch the suture loop (bight ofsuture) to the upper jaw after passing the needle/tissue penetrator fromthe lower jaw to the underside of the upper jaw as described above.

In FIG. 39A, the upper jaw 3901 has a profile that has been thinned inboth the mid portion and in the region of the suture trap (the distalregion) though the combined (overall) thickness of the suturetrap/capture region and distal end of the jaw form a thickness that isgreater than the intermediate region. In FIG. 39A, the intermediateportion 3903 of the upper jaw measures 0.027″ at its thinnest point. Thedistal end, including the suture trap region, measures 0.040″ 3905. Thedecrease in height at the distal end (e.g., the suture trap region) maybe facilitated by an alternate embodiment of the suture traparchitecture shown in FIG. 39A-39C.

Specifically, the suture trap 3921 in FIGS. 39A-36C has channels 3909(visible in FIG. 39B) that may help capture the suture. As the needlepushes the suture into the suture trap 3921, one leg of the suture fallsinto each groove and the bight of the suture is trapped in place withthe leaf spring 3923. The width of the grooves may be approximately thesame size as the diameter of the suture. The opening of the groovescould be larger than this width to facilitate “lead-in” of the suturesinto the grooves. The grooves could also get progressively narrower tocause the sutures to get wedged in to the grooves as the device ispulled back out of the knee.

Both suture legs may fall into the same groove. The relative distancefrom the end of the leaf spring to the end of the groove may be sizedsuch that the diameter of the suture bight is too large to fit throughthe gap, thus the suture trap may also be effective at holding thesuture.

In FIGS. 39A-39C, the leaf spring is shown with tooth-like features inthe distal end (see also FIGS. 35A-35B). This suture trap mechanism mayalso work with a biasing member (e.g., leaf spring) that is straightacross its distal end and/or does not include teeth.

As shown, described, and used herein, a radius surface is generallycurved to have a radius of curvature between the surface and somecentral point or region; the radiused surface does not need to form aportion of a circle, but may generally form an arc of a circle (e.g. theradius of curvature of the approximately-circular arc maybe +/− somepercent, e.g., 5%, 10%, 15%, 20%, etc.). The radiused surface may referto the outer surface in cross-section (e.g., in a longitudinal plane).

When a feature or element is herein referred to as being “on” anotherfeature or element, it can be directly on the other feature or elementor intervening features and/or elements may also be present. Incontrast, when a feature or element is referred to as being “directlyon” another feature or element, there are no intervening features orelements present. It will also be understood that, when a feature orelement is referred to as being “connected”, “attached” or “coupled” toanother feature or element, it can be directly connected, attached orcoupled to the other feature or element or intervening features orelements may be present. In contrast, when a feature or element isreferred to as being “directly connected”, “directly attached” or“directly coupled” to another feature or element, there are nointervening features or elements present. Although described or shownwith respect to one embodiment, the features and elements so describedor shown can apply to other embodiments. It will also be appreciated bythose of skill in the art that references to a structure or feature thatis disposed “adjacent” another feature may have portions that overlap orunderlie the adjacent feature.

Terminology used herein is for the purpose of describing particularembodiments only and is not intended to be limiting of the invention.For example, as used herein, the singular forms “a”, “an” and “the” areintended to include the plural forms as well, unless the context clearlyindicates otherwise. It will be further understood that the terms“comprises” and/or “comprising,” when used in this specification,specify the presence of stated features, steps, operations, elements,and/or components, but do not preclude the presence or addition of oneor more other features, steps, operations, elements, components, and/orgroups thereof. As used herein, the term “and/or” includes any and allcombinations of one or more of the associated listed items and may beabbreviated as “/”.

Spatially relative terms, such as “under”, “below”, “lower”, “over”,“upper” and the like, may be used herein for ease of description todescribe one element or feature's relationship to another element(s) orfeature(s) as illustrated in the figures. It will be understood that thespatially relative terms are intended to encompass differentorientations of the device in use or operation in addition to theorientation depicted in the figures. For example, if a device in thefigures is inverted, elements described as “under” or “beneath” otherelements or features would then be oriented “over” the other elements orfeatures. Thus, the exemplary term “under” can encompass both anorientation of over and under. The device may be otherwise oriented(rotated 90 degrees or at other orientations) and the spatially relativedescriptors used herein interpreted accordingly. Similarly, the terms“upwardly”, “downwardly”, “vertical”, “horizontal” and the like are usedherein for the purpose of explanation only unless specifically indicatedotherwise.

Although the terms “first” and “second” may be used herein to describevarious features/elements, these features/elements should not be limitedby these terms, unless the context indicates otherwise. These terms maybe used to distinguish one feature/element from another feature/element.Thus, a first feature/element discussed below could be termed a secondfeature/element, and similarly, a second feature/element discussed belowcould be termed a first feature/element without departing from theteachings of the present invention.

As used herein in the specification and claims, including as used in theexamples and unless otherwise expressly specified, all numbers may beread as if prefaced by the word “about” or “approximately,” even if theterm does not expressly appear. The phrase “about” or “approximately”may be used when describing magnitude and/or position to indicate thatthe value and/or position described is within a reasonable expectedrange of values and/or positions. For example, a numeric value may havea value that is +/−0.1% of the stated value (or range of values), +/−1%of the stated value (or range of values), +/−2% of the stated value (orrange of values), +/−5% of the stated value (or range of values), +/−10%of the stated value (or range of values), etc. Any numerical rangerecited herein is intended to include all sub-ranges subsumed therein.

Although various illustrative embodiments are described above, any of anumber of changes may be made to various embodiments without departingfrom the scope of the invention as described by the claims. For example,the order in which various described method steps are performed mayoften be changed in alternative embodiments, and in other alternativeembodiments one or more method steps may be skipped altogether. Optionalfeatures of various device and system embodiments may be included insome embodiments and not in others. Therefore, the foregoing descriptionis provided primarily for exemplary purposes and should not beinterpreted to limit the scope of the invention as it is set forth inthe claims.

The examples and illustrations included herein show, by way ofillustration and not of limitation, specific embodiments in which thesubject matter may be practiced. As mentioned, other embodiments may beutilized and derived there from, such that structural and logicalsubstitutions and changes may be made without departing from the scopeof this disclosure. Such embodiments of the inventive subject matter maybe referred to herein individually or collectively by the term“invention” merely for convenience and without intending to voluntarilylimit the scope of this application to any single invention or inventiveconcept, if more than one is, in fact, disclosed. Thus, althoughspecific embodiments have been illustrated and described herein, anyarrangement calculated to achieve the same purpose may be substitutedfor the specific embodiments shown. This disclosure is intended to coverany and all adaptations or variations of various embodiments.Combinations of the above embodiments, and other embodiments notspecifically described herein, will be apparent to those of skill in theart upon reviewing the above description.

We claim:
 1. A suture passer device for passing a suture through ameniscus, the device comprising: an elongate body having a length andextending distally and proximally along a long axis; a first armextending from the distal end of the elongate body, a second armextending distally from the elongate body, wherein an upper surface ofthe second arm is radiused and curves away from the long axis; furtherwherein the first arm and the second arm form a distal-facing openingbetween the second arm and the first arm; and a tissue penetratorconfigured to extend across the distal-facing opening between the firstand second arms to pass a suture there between, wherein the tissuepenetrator is housed within either the first arm or the second arm. 2.The device of claim 1, wherein the first arm is connected to theelongate body and is axially movable distally and proximally relative tothe elongate body along the long axis.
 3. The device of claim 1, whereinthe tissue penetrator is housed within the first arm.
 4. The device ofclaim 1, wherein the first arm is configured to move axially in the longaxis.
 5. The device of claim 1, wherein the upper surface of the secondarm is radiused with a radius of curvature of between about 0.5 cm andabout 20 cm.
 6. The device of claim 1, wherein a lower surface, oppositefrom the upper surface of the second arm, is less curved or un-curvedthan the upper surface of the second arm.
 7. The device of claim 1,wherein the upper surface of the second arm is radiused with a radius ofcurvature of between about 1 cm and about 10 cm.
 8. The device of claim1, wherein the second arm is pivotably attached to the distal end regionof the elongate body.
 9. The device of claim 1, wherein a lower surfaceof the second arm that is opposite from the upper surface is less curvedthan the upper surface of the second arm.
 10. The device of claim 1,wherein a lower surface of the second arm that is opposite from theupper surface is less curved than the upper surface of the second arm sothat the thickness of the second arm is thinner more proximally thandistally.
 11. The device of claim 1, wherein the tissue penetrator isconfigured to releasably couple to the suture to carry the suturethrough a tissue.
 12. The device of claim 1, wherein the distal-facingopening is an acute-angled distal-facing opening configured to fit ameniscus therein.
 13. The device of claim 1, wherein the tissuepenetrator comprises a shape memory alloy.
 14. The device of claim 1,wherein the tissue penetrator extends from a position completely withinthe first arm to extend across the distal-facing opening from the firstarm to the second arm.
 15. A suture passer device for passing a suturethrough a meniscus, the device comprising: an elongate body extendingdistally and proximally along a long axis; a first arm that extends fromthe elongate body and is axially movable distally and proximallyrelative to the elongate body along the long axis; a second armextending distally from the elongate body, wherein an upper surface ofthe second arm is radiused with a radius of curvature of between about0.5 cm and about 20 cm and curves away from the long axis; furtherwherein the first arm and the second arm form a distal-facing openingbetween the second arm and the first arm; and a tissue penetratorconfigured to extend across the distal opening between the first andsecond arms to pass the suture there between.
 16. The device of claim15, wherein the tissue penetrator is housed within the first arm. 17.The device of claim 15, wherein the second arm is pivotably attached tothe distal end region of the elongate body.
 18. The device of claim 15,wherein the tissue penetrator is configured to releasably couple to thesuture to carry the suture through a tissue.
 19. The device of claim 15,wherein the distal opening is an acute-angled distal-facing openingconfigured to fit a meniscus therein.
 20. The device of claim 15,wherein the tissue penetrator comprises a shape memory alloy.
 21. Thedevice of claim 15, wherein the tissue penetrator extends from aposition completely within the first arm as it extends across the distalopening from the first arm to the second arm.
 22. The device of claim15, wherein the upper surface of the second arm is radiused with aradius of curvature of between about 1 cm and about 10 cm.
 23. Thedevice of claim 15, wherein a lower surface of the second arm that isopposite from the upper surface is less curved than the upper surface ofthe second arm.
 24. The device of claim 15, wherein a lower surface ofthe second arm that is opposite from the upper surface is less curvedthan the upper surface of the second arm so that the thickness of thesecond arm is thinner more proximally than distally.
 25. A suture passerdevice for passing a suture through the meniscus, the device comprising:an elongate body having a length and extending distally and proximallyalong a long axis; a first arm that is axially movable distally andproximally relative to the elongate body along the long axis, a secondarm extending distally from the elongate body, wherein an upper surfaceof the second arm is radiused with a radius of curvature of betweenabout 0.5 cm and about 20 cm; further wherein the second arm ispivotably attached to a distal end region of the elongate body and thefirst arm and second arm form a distal-facing opening between the distalregion of the second arm and the distal region of the removable firstarm when the removable first arm is extended distally; and a tissuepenetrator housed within the first arm that is configured to extendacross the distal-facing opening to pass a suture there between.
 26. Thedevice of claim 25, wherein the radius of curvature of the upper surfaceis between about 1 cm and about 10 cm.
 27. The device of claim 25,wherein the tissue penetrator is configured to releasably couple to thesuture to carry the suture through a tissue.
 28. The device of claim 25,wherein the distal-facing opening is an acute-angled distal-facingopening configured to fit a meniscus therein.
 29. The device of claim25, wherein the tissue penetrator comprises a shape memory alloy. 30.The device of claim 25, wherein a lower surface of the second arm thatis opposite from the upper surface is less curved than the upper surfaceof the second arm so that the thickness of the second arm is thinnermore proximally than distally.